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Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TS022
Vehicle
Sponsored by
Taisho Pharmaceutical R&D Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis, Pruritus

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults, males or females, 18 - 65 years of age at the time of obtaining the written Informed Consent
  2. Generally healthy subjects, who have no past or present history of any significant and/or newly-diagnosed disease or condition
  3. A score of 2 (Mild Disease), 3 (Moderate Disease) or 4 (Severe Disease) on the Investigator's Global Assessment of Atopic Dermatitis (IGA) Scale
  4. A score of 2 (Moderate Pruritus), 3 (Severe Pruritus) or 4 (Very Severe Pruritus) on the Five-Point Pruritus Scale
  5. Patient satisfies the diagnostic criteria for AD as determined by the criteria of Hanifin and Rajka
  6. Patient understands the study procedures and agrees to participate in the study by giving written Informed Consent
  7. Ability to read and understand English and to provide written informed consent and authorization for protected health information disclosure

Exclusion Criteria:

  1. Concurrent skin pathology or recent history (within the past 5 years) of a chronic skin disease other than AD
  2. Use of phototherapy, including exposure to tanning beds, within 28 days of Study Drug application
  3. Taking systemic immunosuppressive drugs, biologicals, or corticosteroids therapy within (14 days), or topical immunosuppressive drugs or corticosteroid therapy (within 7 days) of Study Drug application
  4. Females who are planning a pregnancy, who are pregnant, or who are breastfeeding
  5. Inability or unwillingness to discontinue current AD treatment(s)
  6. Inability or unwillingness to comply with study visit schedule and/or other study activities as required by the study protocol

Sites / Locations

  • UCSD
  • Therapeutics Clinical Research
  • Ameriderm Research
  • Ameriderm Research
  • FXM Research
  • Ameriderm Research
  • Gwinnett Clinical Research
  • Minnesota Clinical Study Center
  • Comprehensive Clinical Research
  • Wake Forest University
  • Haber Dermatology and Cosmetic Surgery, Inc
  • Oregon Health and Science University
  • J & S Studies
  • Center for Clinical Studies
  • Center for Clinical Studies

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Vehicle

TS-022 0.005% lotion

TS-022 0.010% lotion

TS-022 0.020% lotion

Arm Description

Outcomes

Primary Outcome Measures

Change in Pruritis Visual Analog Scale (VAS)
Patient reported outcome of pruritis measurement (0-100 mm/min-max)on a change in visual analog scale
Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events
Safety assessment of all subjects who received investigational product. Outcome measure is number of subjects with an adverse event. Measures of adverse events in participants included vital signs, laboratory findings, physical exams, electrocardiograms
Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas
investigator assessment of disease status rated on 0-5 scale (0 = clear to 5 = very severe) based on a change in score from baseline to Study Day 36 (Visit 7)
Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score
self-assessment using a five point scale of pruritus state based on a change in scale from none (0) to very severe (4), interfering with daily or sleep activities. Subjects will complete the Five-Point Pruritus Scale once at Screening (Visit 1), then twice daily beginning at baseline, which occurs on the morning of Study Day -7 (Visit 2), through Study Day 36 (Visit 7)
Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas
The head and neck [10%], trunk [30%], upper extremities [20%] and lower extremities [40%] were assessed separately for erythema (E), infiltration/papulation (I), excoriation (Ex) and lichenification (L) represented by a numeric coded value of (0, No eruption) to (6, 90% - 100% eruption). One score given to each part of the body on a scale from 1-6 based on the four attributes (E, I, Ex, L) and then a proportional average is taken to get a total score of 1-6.
Skindex-29 Questionnaire to Measure the Subject's Overall Quality of Life Based on Activities of Daily Living That Affect Change in Emotion (10 to 50 Points), Symptoms (7 to 35 Points) and Functioning (12 to 60 Points) to Skin Over One Week Period.
Assessment of subject's activities of daily living using the SKINDEX-29 questionnaire to measure the subject's overall quality of life based on a change in scale from baseline. The SKINDEX scoring scale has a range of 29-145. The smaller the number the better the patient feels. The results are the difference of the SKINDEX scoring scale at treatment discharge (day 22) minus baseline (day-7). Hence the results should be negative, as the patient's emotion, symptoms and functioning of the skin should feel better at treatment discharge as opposed to baseline.
Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale
Pruritis Visual Analog Scale (VAS) based on patient reported outcome of pruritis measurement on a VAS indicating the amount of pruritus (itchiness) experienced from the time of last dose application through the time just before current dose application. Change in pruritus is assessed twice daily beginning at baseline, Study Day -7 (Visit 2), through Study Day 36 (Visit 7). Subjects determine measurable pruritis using a visual horizontal analog scale ranging from "No Itch", even the slightest itch or "Slight Itch", to "Worst Itch Imaginable" to denote the increase in severity of itching.

Secondary Outcome Measures

Full Information

First Posted
May 28, 2009
Last Updated
November 30, 2011
Sponsor
Taisho Pharmaceutical R&D Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00914186
Brief Title
Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)
Official Title
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study of the Efficacy, Safety and Tolerability of TS-022 in Adult Patients With a Diagnosis of Atopic Dermatitis (AD) With Moderate to Very Severe Pruritus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taisho Pharmaceutical R&D Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose and (primary) objectives of this study are to evaluate the efficacy, safety, and tolerability of TS-022 in adults with atopic dermatitis who have moderate to very severe pruritus (itching), following a 28-day regimen of twice-daily topical application.
Detailed Description
(none provided)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis, Pruritus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
122 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Title
TS-022 0.005% lotion
Arm Type
Experimental
Arm Title
TS-022 0.010% lotion
Arm Type
Experimental
Arm Title
TS-022 0.020% lotion
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TS022
Intervention Description
Lotion
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Lotion
Primary Outcome Measure Information:
Title
Change in Pruritis Visual Analog Scale (VAS)
Description
Patient reported outcome of pruritis measurement (0-100 mm/min-max)on a change in visual analog scale
Time Frame
Baseline through Study Day 36 (Visit 7)
Title
Safety and Tolerability of TS-022 Topical Lotion as Measured by Participants Who Demonstrated Adverse Events
Description
Safety assessment of all subjects who received investigational product. Outcome measure is number of subjects with an adverse event. Measures of adverse events in participants included vital signs, laboratory findings, physical exams, electrocardiograms
Time Frame
Baseline through Study Day 36 (Visit 7)
Title
Investigator's Global Assessment (IGA) Based on a Dermatologist's Evalution of the Change in Subject's Score of Target Treatment Areas
Description
investigator assessment of disease status rated on 0-5 scale (0 = clear to 5 = very severe) based on a change in score from baseline to Study Day 36 (Visit 7)
Time Frame
baseline through Study Day 36 (Visit 7)
Title
Five Point Pruritus Scale for Self-Assessment of Target Treatment Area Based on a Change in Score
Description
self-assessment using a five point scale of pruritus state based on a change in scale from none (0) to very severe (4), interfering with daily or sleep activities. Subjects will complete the Five-Point Pruritus Scale once at Screening (Visit 1), then twice daily beginning at baseline, which occurs on the morning of Study Day -7 (Visit 2), through Study Day 36 (Visit 7)
Time Frame
Baseline, which is Day -7 (Visit 2), through Day 36 (Visit 7)
Title
Eczema Area and Severity Index (EASI) Based on a Change in Score of Eruption in Proportionate Body Surface Areas
Description
The head and neck [10%], trunk [30%], upper extremities [20%] and lower extremities [40%] were assessed separately for erythema (E), infiltration/papulation (I), excoriation (Ex) and lichenification (L) represented by a numeric coded value of (0, No eruption) to (6, 90% - 100% eruption). One score given to each part of the body on a scale from 1-6 based on the four attributes (E, I, Ex, L) and then a proportional average is taken to get a total score of 1-6.
Time Frame
baseline through Study Day 36 (Visit 7)
Title
Skindex-29 Questionnaire to Measure the Subject's Overall Quality of Life Based on Activities of Daily Living That Affect Change in Emotion (10 to 50 Points), Symptoms (7 to 35 Points) and Functioning (12 to 60 Points) to Skin Over One Week Period.
Description
Assessment of subject's activities of daily living using the SKINDEX-29 questionnaire to measure the subject's overall quality of life based on a change in scale from baseline. The SKINDEX scoring scale has a range of 29-145. The smaller the number the better the patient feels. The results are the difference of the SKINDEX scoring scale at treatment discharge (day 22) minus baseline (day-7). Hence the results should be negative, as the patient's emotion, symptoms and functioning of the skin should feel better at treatment discharge as opposed to baseline.
Time Frame
Study Day -7 through Study Day 22
Title
Number of Participants Who Had Measurable Pruritis Based on a Visual Horizontal Analog Scale
Description
Pruritis Visual Analog Scale (VAS) based on patient reported outcome of pruritis measurement on a VAS indicating the amount of pruritus (itchiness) experienced from the time of last dose application through the time just before current dose application. Change in pruritus is assessed twice daily beginning at baseline, Study Day -7 (Visit 2), through Study Day 36 (Visit 7). Subjects determine measurable pruritis using a visual horizontal analog scale ranging from "No Itch", even the slightest itch or "Slight Itch", to "Worst Itch Imaginable" to denote the increase in severity of itching.
Time Frame
Baseline through Study Day 36 (Visit 7)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults, males or females, 18 - 65 years of age at the time of obtaining the written Informed Consent Generally healthy subjects, who have no past or present history of any significant and/or newly-diagnosed disease or condition A score of 2 (Mild Disease), 3 (Moderate Disease) or 4 (Severe Disease) on the Investigator's Global Assessment of Atopic Dermatitis (IGA) Scale A score of 2 (Moderate Pruritus), 3 (Severe Pruritus) or 4 (Very Severe Pruritus) on the Five-Point Pruritus Scale Patient satisfies the diagnostic criteria for AD as determined by the criteria of Hanifin and Rajka Patient understands the study procedures and agrees to participate in the study by giving written Informed Consent Ability to read and understand English and to provide written informed consent and authorization for protected health information disclosure Exclusion Criteria: Concurrent skin pathology or recent history (within the past 5 years) of a chronic skin disease other than AD Use of phototherapy, including exposure to tanning beds, within 28 days of Study Drug application Taking systemic immunosuppressive drugs, biologicals, or corticosteroids therapy within (14 days), or topical immunosuppressive drugs or corticosteroid therapy (within 7 days) of Study Drug application Females who are planning a pregnancy, who are pregnant, or who are breastfeeding Inability or unwillingness to discontinue current AD treatment(s) Inability or unwillingness to comply with study visit schedule and/or other study activities as required by the study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nermina Nakas, MD
Organizational Affiliation
Clinsys
Official's Role
Study Director
Facility Information:
Facility Name
UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Ameriderm Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Ameriderm Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
FXM Research
City
Miramar
State/Province
Florida
ZIP/Postal Code
33027
Country
United States
Facility Name
Ameriderm Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Gwinnett Clinical Research
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Comprehensive Clinical Research
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Haber Dermatology and Cosmetic Surgery, Inc
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44118
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
J & S Studies
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Center for Clinical Studies
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Center for Clinical Studies
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Study of TS-022 in Adult Patients With Atopic Dermatitis With Pruritus (POC)

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