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Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-06700841
Vehicle (Placebo)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Mild-to-Moderate Atopic Dermatitis, topical

Eligibility Criteria

12 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of Atopic Dermatitis for at least 3 months
  • Investigator's Global Assessment (IGA) Score of 2 or 3
  • Eczema Area Severity Index (EASI) score of 3-21
  • Body Surface Area (BSA) of 2-20%
  • Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

Exclusion Criteria:

  • Other forms of dermatological diseases (other than atopic dermatitis)
  • Fitzpatrick skin type score greater than 5
  • Clinically significant abnormal ECG, vital signs, and laboratory values
  • Infection with HBV, HCV, herpes zoster or tuberculosis

Sites / Locations

  • Clinical Research Center of Alabama, LLC
  • Center for Dermatology and Plastic Surgery/CCT
  • Center for Dermatology and Plastic Surgery
  • California Dermatology & Clinical Research Institute
  • First OC Dermatology
  • Beach Allergy and Asthma Specialty Group, A Medical Corporation
  • Clinical Science Institute
  • New England Associates, LLC
  • Dermatology Physicians of Connecticut
  • Yolanda C. Holmes, MD
  • Olympian Clinical Research
  • Accel Research Sites - DeLand Clinical Research Unit
  • Jacksonville Center for Clinical Research
  • Clinical Neuroscience Solutions, Inc.
  • Precision Imaging
  • Solutions Through Advanced Research, Inc
  • Clinical Neuroscience Solutions, Inc.
  • Leavitt Medical Associates of Florida d/b/a Ameriderm Research
  • Advanced Medical Research PC
  • Sneeze, Wheeze & Itch Associates, LLC
  • DS Research
  • DS Research
  • Meridian Clinical Research, LLC
  • MediSearch Clinical Trials
  • Dermatology Consulting Services, PLLC
  • Lynn Health Science Institute
  • Vital Prospects Clinical Research Institute, PC
  • Health Concepts
  • Tanenbaum Dermatology Center
  • Clinical Neuroscience Solutions, Inc.
  • studies in Dermatology, LLC
  • Center for Clinical Studies, LTD.LLP
  • Ventavia Research Group LLC
  • Center for Clinical Studies, LTD. LLP
  • Summit Clinical Research, LLC
  • Virginia Dermatology and Skin Cancer Center
  • Australian Clinical Research Network
  • Emeritus Research
  • Sinclair Dermatology
  • Cabrini Hospital
  • Center for Skin and Venereal Diseases EOOD - Sofia
  • DCC Alexandrovska
  • Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
  • Wiseman Dermatology Research Inc.
  • SKiN Health
  • Innovaderm Research Inc.
  • Diex Recherche Sherbrooke Inc.
  • Gentofte Hospital
  • Emovis GmbH
  • Rothhaar Studien GmbH
  • ISA - Interdisciplinary Study Association GmbH
  • Klinikum Bielefeld gem.GmbH
  • Universitätsklinikum Bonn AöR
  • Universitätsklinikum Frankfurt
  • MENSINGDERMA research GmbH
  • MVZ Alstermed GmbH
  • Dermatologische Gemeinschaftspraxis
  • Klinische Forschung Schwerin GmbH
  • Semmelweis Egyetem Altalanos Orvostudomanyi Kar
  • Debreceni Egyetem Klinikai Kozpont
  • Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza
  • CRU Hungary Kft.
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
  • Kitago Dermatology Clinic
  • Nakatsuhifuka Clinic
  • Parkside Hiroo Ladies Clinic
  • Tanpopo Skin Clinic
  • Shinjuku Minamiguchi Dermatology Skin Clinic
  • Medical Corporation Jitai-kai Tachikawa Dermatology Clinic
  • Aesthetic dermatology clinic of Prof. J. Kisis
  • Health and Aesthetics Ltd
  • Outpatient Clinic of Ventspils
  • NZOZ Specjalistyczny Ośrodek Dermatologiczny DERMAL s.c.
  • NASZ LEKARZ Przychodnie Medyczne
  • MTZ Clinical Research Sp. z o.o
  • WroMedica I. Bielicka, A. Strzalkowska s.c.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

PF-06700841 0.1% cream QD

PF-06700841 0.3% cream QD

PF-06700841 1% cream QD

PF-06700841 3% cream QD

PF-06700841 0.3% cream BID

PF-06700841 1% cream BID

Vehicle cream QD

Vehicle cream BID

Arm Description

PF-06700841 0.1% cream applied once daily (QD)

PF-06700841 0.3% cream applied once daily (QD)

PF-06700841 1% cream applied once daily (QD)

PF-06700841 3% cream applied once daily (QD)

PF-06700841 0.3% cream applied twice daily (BID)

PF-06700841 1% cream applied twice daily (BID)

Vehicle cream applied once daily (QD)

Vehicle cream applied twice daily (BID)

Outcomes

Primary Outcome Measures

Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.

Secondary Outcome Measures

Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation
IGA assesses severity of participant's AD on a 5 point scale. 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting and 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Higher scores indicating more severity of AD. Assessment excluded soles, palms and scalp.
Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit
4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD.
Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.
Number of Participants With Pre-defined Criteria For Vital Signs
Pre-defined criteria included: 1) Diastolic blood pressure (DBP), a) sitting DBP: change of >= 20 millimeter of mercury (mmHg) increase, b) sitting DBP: change of >=20mmHg decrease, c) supine DBP: less than (<) 50 mmHg, d) supine DBP: change of >= 20mmHg increase, e) supine DBP: change of >= 20mmHg decrease; 2) Systolic blood pressure (SBP), a) sitting SBP: <90 mmHg, b) sitting SBP: change of >=30mmHg increase, c) sitting SBP: change of >=30mmHg decrease, d) supine SBP: change of >=30mmHg increase, e) supine SBP: change of >=30mmHg decrease and f) Supine SBP: value <90mmHg.
Number of Participants With Laboratory Abnormalities
Hemoglobin (HGB),hematocrit,erythrocytes (ery.),HDL cholesterol (chl.)<0.8*lower limit of normal(LLN);reticulocytes (ret.), ret./ery. (%)<0.5*LLN,>1.5*upper limit of normal (ULN);ery. mean corpuscular (EMC) volume,EMC HGB,EMC HGB concentration,potassium,chloride,calcium,bicarbonate<0.9*LLN,>1.1*ULN;platelets<0.5*LLN,>1.75*ULN;leukocytes (leu.),glucose<0.6*LLN,>1.5*ULN;lymphocytes (lym.), lym./leu.(%), neutrophils (neu.), neu./leu. (%), protein,albumin <0.8*LLN,>1.2*ULN;basophils (bas.), bas./leu.(%), eosinophils (eos.), eos./leu., monocytes (mon.), mon./leu.(%), urate >1.2*ULN;bilirubin (total, direct, indirect)>1.5*ULN;aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase>3.0*ULN;urea nitrogen, creatinine, triglycerides, chl.>1.3*ULN; sodium <0.95*LLN,>1.05*ULN; creatine kinase >2.0*ULN;Urine: pH<4.5,>8;glucose, ketones, protein, HGB, urobilinogen,bilirubin,nitrite,leukocyte esterase>=1;ery., leu.>= 20;hyaline casts>1;bacteria>20.
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
Clinically significant ECG criteria included PR interval: value greater than (>) 280 millisecond (msec), percentage change greater than equal to (>=) 25/50 percentage, QRS interval: value >120 msec, percentage change >= 50% and QT interval corrected using the Fridericia's formula (QTCF) value 450 msec and 30<=change<60.
Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Change From Baseline in Lipids Profile Values at Week 6
Lipid parameters that were assessed: high density lipoprotein (HDL) cholesterol, triglycerides, cholesterol, low density lipoprotein (LDL) cholesterol.
Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6
Mean change in total cholesterol/HDL cholesterol ratio was assessed and reported.
Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Blood pressure included supine and sitting systolic and diastolic BP.
Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6
Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Local tolerability skin assessments were performed by the investigator and graded based on severity from grade 0 to 4 as: grade 0=none (no evidence of local intolerance); grade 1=mild (minimal erythema and/or oedema, slight glazed appearance); grade 2= moderate (definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology) grade 3=severe (erythema, oedema glazing with fissures, few vesicles or papules consider removing topical agent [if still in place]) and grade 4= very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent [if still in place]). Higher grades indicated worsening of condition. Only those categories in which at least 1 participant had data were reported.

Full Information

First Posted
March 20, 2019
Last Updated
March 3, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03903822
Brief Title
Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis
Official Title
A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 CREAM APPLIED ONCE OR TWICE DAILY FOR 6 WEEKS IN PARTICIPANTS WITH MILD OR MODERATE ATOPIC DERMATITIS
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
May 13, 2019 (Actual)
Primary Completion Date
May 7, 2020 (Actual)
Study Completion Date
May 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is being conducted to provide data on efficacy, safety, tolerability and PK of multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future clinical development of topical PF-06700841.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Mild-to-Moderate Atopic Dermatitis, topical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-06700841 0.1% cream QD
Arm Type
Experimental
Arm Description
PF-06700841 0.1% cream applied once daily (QD)
Arm Title
PF-06700841 0.3% cream QD
Arm Type
Experimental
Arm Description
PF-06700841 0.3% cream applied once daily (QD)
Arm Title
PF-06700841 1% cream QD
Arm Type
Experimental
Arm Description
PF-06700841 1% cream applied once daily (QD)
Arm Title
PF-06700841 3% cream QD
Arm Type
Experimental
Arm Description
PF-06700841 3% cream applied once daily (QD)
Arm Title
PF-06700841 0.3% cream BID
Arm Type
Experimental
Arm Description
PF-06700841 0.3% cream applied twice daily (BID)
Arm Title
PF-06700841 1% cream BID
Arm Type
Experimental
Arm Description
PF-06700841 1% cream applied twice daily (BID)
Arm Title
Vehicle cream QD
Arm Type
Placebo Comparator
Arm Description
Vehicle cream applied once daily (QD)
Arm Title
Vehicle cream BID
Arm Type
Placebo Comparator
Arm Description
Vehicle cream applied twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
PF-06700841
Intervention Description
PF-06700841 topical cream
Intervention Type
Drug
Intervention Name(s)
Vehicle (Placebo)
Intervention Description
Vehicle topical cream
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
Description
EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 6: Non-responder Imputation
Description
IGA assesses severity of participant's AD on a 5 point scale. 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting and 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Higher scores indicating more severity of AD. Assessment excluded soles, palms and scalp.
Time Frame
Baseline, Week 6
Title
Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 6: Multiple Imputation
Description
EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame
Baseline, Week 6
Title
Percentage of Participants Achieving >=2 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
Description
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time Frame
Baseline, Weeks 1, 2, 3, 4 and 6
Title
Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 1, 2, 3, 4, 6 and Follow-up Visit: Non-responder Imputation
Description
The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: "How would you rate your itch due to AD at the worst moment during the previous 24 hours?" The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch.
Time Frame
Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Title
Percent Change From Baseline in Affected Body Surface Area (BSA) at Weeks 1, 2, 3, 4, 6 and Follow-up Visit
Description
4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranged from 0 to 100%, with higher values representing greater severity of AD.
Time Frame
Baseline, Weeks 1, 2, 3, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Title
Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 1, 2, 3, 4 and 6: Non-responder Imputation
Description
EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD.
Time Frame
Baseline, Weeks 1, 2, 3, 4 and 6
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and all non-SAEs.
Time Frame
Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Title
Number of Participants With Pre-defined Criteria For Vital Signs
Description
Pre-defined criteria included: 1) Diastolic blood pressure (DBP), a) sitting DBP: change of >= 20 millimeter of mercury (mmHg) increase, b) sitting DBP: change of >=20mmHg decrease, c) supine DBP: less than (<) 50 mmHg, d) supine DBP: change of >= 20mmHg increase, e) supine DBP: change of >= 20mmHg decrease; 2) Systolic blood pressure (SBP), a) sitting SBP: <90 mmHg, b) sitting SBP: change of >=30mmHg increase, c) sitting SBP: change of >=30mmHg decrease, d) supine SBP: change of >=30mmHg increase, e) supine SBP: change of >=30mmHg decrease and f) Supine SBP: value <90mmHg.
Time Frame
Baseline up to Week 6
Title
Number of Participants With Laboratory Abnormalities
Description
Hemoglobin (HGB),hematocrit,erythrocytes (ery.),HDL cholesterol (chl.)<0.8*lower limit of normal(LLN);reticulocytes (ret.), ret./ery. (%)<0.5*LLN,>1.5*upper limit of normal (ULN);ery. mean corpuscular (EMC) volume,EMC HGB,EMC HGB concentration,potassium,chloride,calcium,bicarbonate<0.9*LLN,>1.1*ULN;platelets<0.5*LLN,>1.75*ULN;leukocytes (leu.),glucose<0.6*LLN,>1.5*ULN;lymphocytes (lym.), lym./leu.(%), neutrophils (neu.), neu./leu. (%), protein,albumin <0.8*LLN,>1.2*ULN;basophils (bas.), bas./leu.(%), eosinophils (eos.), eos./leu., monocytes (mon.), mon./leu.(%), urate >1.2*ULN;bilirubin (total, direct, indirect)>1.5*ULN;aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase>3.0*ULN;urea nitrogen, creatinine, triglycerides, chl.>1.3*ULN; sodium <0.95*LLN,>1.05*ULN; creatine kinase >2.0*ULN;Urine: pH<4.5,>8;glucose, ketones, protein, HGB, urobilinogen,bilirubin,nitrite,leukocyte esterase>=1;ery., leu.>= 20;hyaline casts>1;bacteria>20.
Time Frame
Baseline (Day 1) up to at least 28 days after last dose of study drug (approximately up to Week 11)
Title
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
Description
Clinically significant ECG criteria included PR interval: value greater than (>) 280 millisecond (msec), percentage change greater than equal to (>=) 25/50 percentage, QRS interval: value >120 msec, percentage change >= 50% and QT interval corrected using the Fridericia's formula (QTCF) value 450 msec and 30<=change<60.
Time Frame
Baseline up to Week 6
Title
Change From Baseline in Clinical Chemistry-Lactate Dehydrogenase Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Time Frame
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Title
Change From Baseline in Clinical Chemistry- Protein and Albumin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Time Frame
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Title
Change From Baseline in Clinical Chemistry- Urea Nitrogen, Urate, Calcium and Glucose Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Time Frame
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Title
Change From Baseline in Clinical Chemistry- Sodium, Potassium, Chloride and Bicarbonate Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Time Frame
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Title
Change From Baseline in Hematology- Hemoglobin Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Time Frame
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Title
Change From Baseline in Hematology - Hematocrit, Reticulocytes/Erythrocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes, Basophils/Leukocytes, Eosinophils/Leukocytes and Monocytes/Leukocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Time Frame
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Title
Change From Baseline in Hematology- Erythrocytes and Reticulocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Time Frame
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Title
Change From Baseline in Hematology- Platelets, Leukocytes, Lymphocytes, Neutrophils, Basophils, Eosinophils and Monocytes Laboratory Values at Weeks 1, 2, 4, 6 and Follow-up Visit
Time Frame
Baseline, Weeks 1, 2, 4, 6 and follow up visit (28 days after last dose of study drug = maximum up to Day 71)
Title
Change From Baseline in Lipids Profile Values at Week 6
Description
Lipid parameters that were assessed: high density lipoprotein (HDL) cholesterol, triglycerides, cholesterol, low density lipoprotein (LDL) cholesterol.
Time Frame
Baseline, Week 6
Title
Change From Baseline in Ratio of LDL Cholesterol to HDL Cholesterol Lipids Profile at Week 6
Description
Mean change in total cholesterol/HDL cholesterol ratio was assessed and reported.
Time Frame
Baseline, Week 6
Title
Change From Baseline in Electrocardiogram (ECG) Parameter- Heart Rate at Weeks 2 and 6
Time Frame
Baseline, Weeks 2 and 6
Title
Change From Baseline in PR, QRS, QTCF and QT Interval at Weeks 2 and 6
Time Frame
Baseline, Weeks 2 and 6
Title
Change From Baseline in Vital Signs- Blood Pressure (BP) at Weeks 2 and 6
Description
Blood pressure included supine and sitting systolic and diastolic BP.
Time Frame
Baseline, Weeks 2 and 6
Title
Change From Baseline in Vital Signs- Pulse Rate at Weeks 2 and 6
Time Frame
Baseline, Weeks 2 and 6
Title
Change From Baseline in Vital Signs- Temperature at Weeks 2 and 6
Time Frame
Baseline, Weeks 2 and 6
Title
Number of Participants With Each Severity Grade in Local Tolerability Assessments
Description
Local tolerability skin assessments were performed by the investigator and graded based on severity from grade 0 to 4 as: grade 0=none (no evidence of local intolerance); grade 1=mild (minimal erythema and/or oedema, slight glazed appearance); grade 2= moderate (definite erythema and/or oedema with peeling and/or cracking but needs no adaptation of posology) grade 3=severe (erythema, oedema glazing with fissures, few vesicles or papules consider removing topical agent [if still in place]) and grade 4= very severe (strong reaction spreading beyond the treated area, bullous reaction, erosions: removal of topical agent [if still in place]). Higher grades indicated worsening of condition. Only those categories in which at least 1 participant had data were reported.
Time Frame
Day 1 and any day on of Week 1, 2, 4, 6: pre dose (before application of IP) and post dose (after application of IP); Follow up visit (28 days after last dose of study drug = maximum up to Day 71) and Early termination (anytime within week 11)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of Atopic Dermatitis for at least 3 months Investigator's Global Assessment (IGA) Score of 2 or 3 Eczema Area Severity Index (EASI) score of 3-21 Body Surface Area (BSA) of 2-20% Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more Exclusion Criteria: Other forms of dermatological diseases (other than atopic dermatitis) Fitzpatrick skin type score greater than 5 Clinically significant abnormal ECG, vital signs, and laboratory values Infection with HBV, HCV, herpes zoster or tuberculosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Center of Alabama, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Center for Dermatology and Plastic Surgery/CCT
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Center for Dermatology and Plastic Surgery
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
California Dermatology & Clinical Research Institute
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Beach Allergy and Asthma Specialty Group, A Medical Corporation
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
Clinical Science Institute
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
New England Associates, LLC
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Dermatology Physicians of Connecticut
City
Shelton
State/Province
Connecticut
ZIP/Postal Code
06484
Country
United States
Facility Name
Yolanda C. Holmes, MD
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Olympian Clinical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Accel Research Sites - DeLand Clinical Research Unit
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Precision Imaging
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Solutions Through Advanced Research, Inc
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Leavitt Medical Associates of Florida d/b/a Ameriderm Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Advanced Medical Research PC
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Sneeze, Wheeze & Itch Associates, LLC
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
DS Research
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
DS Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
MediSearch Clinical Trials
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Dermatology Consulting Services, PLLC
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, PC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Health Concepts
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57702
Country
United States
Facility Name
Tanenbaum Dermatology Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38117
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
studies in Dermatology, LLC
City
Cypress
State/Province
Texas
ZIP/Postal Code
77433
Country
United States
Facility Name
Center for Clinical Studies, LTD.LLP
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Ventavia Research Group LLC
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Center for Clinical Studies, LTD. LLP
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Summit Clinical Research, LLC
City
Franklin
State/Province
Virginia
ZIP/Postal Code
23851
Country
United States
Facility Name
Virginia Dermatology and Skin Cancer Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Australian Clinical Research Network
City
Maroubra
State/Province
New South Wales
ZIP/Postal Code
2035
Country
Australia
Facility Name
Emeritus Research
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Sinclair Dermatology
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Cabrini Hospital
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Center for Skin and Venereal Diseases EOOD - Sofia
City
Sofia
ZIP/Postal Code
1404
Country
Bulgaria
Facility Name
DCC Alexandrovska
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Diagnostic Consultative Center - Fokus-5 - Medical Establishment for Outpatient Care OOD
City
Sofia
ZIP/Postal Code
1463
Country
Bulgaria
Facility Name
Wiseman Dermatology Research Inc.
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3M 3Z4
Country
Canada
Facility Name
SKiN Health
City
Cobourg
State/Province
Ontario
ZIP/Postal Code
K9A 4J9
Country
Canada
Facility Name
Innovaderm Research Inc.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 2V1
Country
Canada
Facility Name
Diex Recherche Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Facility Name
Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Emovis GmbH
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Rothhaar Studien GmbH
City
Berlin
ZIP/Postal Code
10783
Country
Germany
Facility Name
ISA - Interdisciplinary Study Association GmbH
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Klinikum Bielefeld gem.GmbH
City
Bielefeld
ZIP/Postal Code
33647
Country
Germany
Facility Name
Universitätsklinikum Bonn AöR
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
MENSINGDERMA research GmbH
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
MVZ Alstermed GmbH
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Dermatologische Gemeinschaftspraxis
City
Mahlow
ZIP/Postal Code
15831
Country
Germany
Facility Name
Klinische Forschung Schwerin GmbH
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Bacs-Kiskun Megyei Korhaz Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Oktato Korhaza
City
Kecskemet
ZIP/Postal Code
6000
Country
Hungary
Facility Name
CRU Hungary Kft.
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Kitago Dermatology Clinic
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
003-0833
Country
Japan
Facility Name
Nakatsuhifuka Clinic
City
Kita-ku, Osaka-shi
State/Province
Osaka
ZIP/Postal Code
531-0072
Country
Japan
Facility Name
Parkside Hiroo Ladies Clinic
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
106-0047
Country
Japan
Facility Name
Tanpopo Skin Clinic
City
Ota Ku
State/Province
Tokyo
ZIP/Postal Code
143-0023
Country
Japan
Facility Name
Shinjuku Minamiguchi Dermatology Skin Clinic
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
Medical Corporation Jitai-kai Tachikawa Dermatology Clinic
City
Tachikawa
State/Province
Tokyo
ZIP/Postal Code
190-0023
Country
Japan
Facility Name
Aesthetic dermatology clinic of Prof. J. Kisis
City
Riga
ZIP/Postal Code
LV-1003
Country
Latvia
Facility Name
Health and Aesthetics Ltd
City
Riga
ZIP/Postal Code
LV-1009
Country
Latvia
Facility Name
Outpatient Clinic of Ventspils
City
Ventspils
ZIP/Postal Code
LV3601
Country
Latvia
Facility Name
NZOZ Specjalistyczny Ośrodek Dermatologiczny DERMAL s.c.
City
Bialystok
ZIP/Postal Code
15-453
Country
Poland
Facility Name
NASZ LEKARZ Przychodnie Medyczne
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
MTZ Clinical Research Sp. z o.o
City
Warszawa
ZIP/Postal Code
02-106
Country
Poland
Facility Name
WroMedica I. Bielicka, A. Strzalkowska s.c.
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7931022
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis

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