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Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tapinarof cream, 1%
Sponsored by
Dermavant Sciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring eczema, pediatric, tapinarof, phase 3, topical

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

For Roll-over Subjects Only:

  • Met the criteria as a Study Completer in one of three studies (DMVT-505-3101 study, DMVT-505-3102 study, or DMVT-505-2104 study).
  • Must not be pregnant at Baseline

For Direct-Enrolling Subjects Only:

  • Male and female subjects ages 2 years to < 18 years at the time of consent with clinical diagnosis of AD
  • Subjects with a vIGA-AD™ score of ≥ 3 and AD covering ≥ 40% of the BSA at Screening and Baseline (pre-randomization), or subjects with a vIGA-AD™ score of 2 at Screening and Baseline (pre-randomization) regardless of BSA. Subjects must have screened for the DMVT-505-3101 or DMVT-505-3102 study and failed to meet BSA and/or vIGA-AD™ eligibility criteria.
  • AD present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old
  • Must not be pregnant at Screening or Baseline

For All Subjects:

  • Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods
  • Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent

Exclusion Criteria:

For Rollover Subjects Only:

  1. Subjects who were not receiving study drug at the time of the last visit in the pivotal study (DMVT-505-3101, DMVT-505-3102, or DMVT-505-2104)
  2. Used a prohibited concomitant product or procedure to treat AD during the pivotal study.
  3. Had an SAE that was related to treatment or experienced an AE that led to permanent discontinuation of treatment in the pivotal study.
  4. Pregnant females

For Direct-Enrolling Subjects:

  • Immunocompromised at screening
  • Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals within one week prior to baseline visit
  • Significant dermatological or inflammatory condition other than AD that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN).
  • Screening total bilirubin > 1.5x ULN
  • Current or chronic history of liver disease
  • Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
  • Subjects who would not be considered suitable for topical therapy
  • Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer)
  • History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's participation in the study, interpretation of results, or ability to understand and give informed consent.
  • Pregnant or lactating females
  • History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation
  • Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)

Sites / Locations

  • Dermavant Clinical SiteRecruiting
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tapinarof cream

Arm Description

Tapinarof 1%, cream

Outcomes

Primary Outcome Measures

Adverse Events and Serious Adverse Events
Incidence, Frequency, and duration of treatment emergent adverse events
Number of subjects with clinically significant laboratory test abnormalities
Number of subjects with clinically significant vital signs abnormalities
Mean Investigator- and Subject (or Caregiver)-assessed LTS scores by visit
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation.

Secondary Outcome Measures

Proportion of subjects who experience vIGA-AD of clear (0) after treatment
The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting.
Proportion of subjects who experience vIGA-AD score of clear or almost clear (0 or 1) after treatment
The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point (0-4) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Higher vIGA-AD scores represents more severe disease.
Proportion of subjects who do not experience disease worsening (vIGA-AD ≥ 2)
The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point (0-4) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Higher vIGA-AD scores represents more severe disease.
Absolute value, change and percent change from Baseline in %BSA affected by visit
The assessment of %BSA affected is an estimate of the percentage of total involved skin with AD. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by AD will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.
Absolute value, change and percent change from Baseline in Eczema Area and Severity Index (EASI) score by visit
The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.
Proportion of subjects with ≥ 50%, 75%, and 90% improvement in EASI score from Baseline by visit
The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.
Mean change in PP- NRS score
The PP-NRS is a scale from 0-10 used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus. Higher PP-NRS ratings represent more itch reported.
Proportion of subjects with a Baseline PP-NRS score ≥ 4 who achieve ≥ 4-point reduction in the PP-NRS from Baseline at each study visit
The PP-NRS is a scale used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus.Higher PP-NRS ratings represent more itch reported.

Full Information

First Posted
October 29, 2021
Last Updated
January 28, 2022
Sponsor
Dermavant Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05142774
Brief Title
Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis
Official Title
An Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of Tapinarof Cream, 1% in Subjects With Atopic Dermatitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermavant Sciences, Inc.

4. Oversight

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

5. Study Description

Brief Summary
This is an open-label, long-term multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in subjects with atopic dermatitis. Subjects in this study have completed treatment in one of two Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) or completed treatment in the DMVT-505-2104 study, or directly enrolled into this study. This study will consist of up to 48 weeks of treatment and a 1 week safety follow-up period.
Detailed Description
At the completion of the Week 8 visit of study DMVT-505-3101 or study DMVT-505-3102 or the Day 28 visit of study DMVT-505-2104, or Day 1 (Baseline) in this study, all eligible subjects will be offered enrollment in this open-label long-term extension (OL-LTE) study. Approximately 125 additional pediatric subjects ages 2 to < 18 years who are not eligible for participation in the Phase 3 pivotal studies (DMVT-505-3101 or DMVT-505-3102) will be enrolled directly into this OL-LTE study. Study visits during the treatment period for all subjects will occur every 4 weeks (± 3 days). The total duration of study participation will be approximately 49 weeks for rollover subjects (Baseline to Follow-up) and approximately 53 weeks for direct-enrolling subjects (Screening to Follow-up).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
eczema, pediatric, tapinarof, phase 3, topical

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
961 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tapinarof cream
Arm Type
Experimental
Arm Description
Tapinarof 1%, cream
Intervention Type
Drug
Intervention Name(s)
Tapinarof cream, 1%
Intervention Description
Tapinarof cream, 1%, applied daily
Primary Outcome Measure Information:
Title
Adverse Events and Serious Adverse Events
Description
Incidence, Frequency, and duration of treatment emergent adverse events
Time Frame
Baseline to Week 49
Title
Number of subjects with clinically significant laboratory test abnormalities
Time Frame
Baseline up to Week 49
Title
Number of subjects with clinically significant vital signs abnormalities
Time Frame
Baseline up to Week 49
Title
Mean Investigator- and Subject (or Caregiver)-assessed LTS scores by visit
Description
Local Tolerability Scale (LTS) is a clinical tool for assessing the presence and overall degree of irritation at the application sites, according to a 5-point scale (0-4). Higher LTS scores represent more severe irritation.
Time Frame
Baseline up to Week 48
Secondary Outcome Measure Information:
Title
Proportion of subjects who experience vIGA-AD of clear (0) after treatment
Description
The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting.
Time Frame
Baseline up to Week 48
Title
Proportion of subjects who experience vIGA-AD score of clear or almost clear (0 or 1) after treatment
Description
The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point (0-4) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Higher vIGA-AD scores represents more severe disease.
Time Frame
Baseline up to Week 48
Title
Proportion of subjects who do not experience disease worsening (vIGA-AD ≥ 2)
Description
The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint. It is a static 5-point (0-4) morphological assessment of overall disease severity, as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. Higher vIGA-AD scores represents more severe disease.
Time Frame
Baseline up to Week 48
Title
Absolute value, change and percent change from Baseline in %BSA affected by visit
Description
The assessment of %BSA affected is an estimate of the percentage of total involved skin with AD. For the purpose of clinical estimation, the total palmar surface of the subject's palm and digits may be assumed to be approximately equivalent to 1% BSA. The %BSA affected by AD will be evaluated (from 0% to 100%). %BSA is a static assessment made without reference to previous scores.
Time Frame
Baseline to each visit
Title
Absolute value, change and percent change from Baseline in Eczema Area and Severity Index (EASI) score by visit
Description
The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.
Time Frame
Baseline to each visit
Title
Proportion of subjects with ≥ 50%, 75%, and 90% improvement in EASI score from Baseline by visit
Description
The EASI scoring system is a clinical tool that quantifies the severity of a subject's AD based on both lesion severity and %BSA affected. The EASI is a composite score ranging from 0 to 72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. Higher EASI scores indicate more severe disease.
Time Frame
Baseline to each visit
Title
Mean change in PP- NRS score
Description
The PP-NRS is a scale from 0-10 used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus. Higher PP-NRS ratings represent more itch reported.
Time Frame
Baseline to each visit
Title
Proportion of subjects with a Baseline PP-NRS score ≥ 4 who achieve ≥ 4-point reduction in the PP-NRS from Baseline at each study visit
Description
The PP-NRS is a scale used to assess itch/pruritus severity over a 24-hour period which will be used daily to assess peak pruritus.Higher PP-NRS ratings represent more itch reported.
Time Frame
Baseline to each visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For Roll-over Subjects Only: Met the criteria as a Study Completer in one of three studies (DMVT-505-3101 study, DMVT-505-3102 study, or DMVT-505-2104 study). Must not be pregnant at Baseline For Direct-Enrolling Subjects Only: Male and female subjects ages 2 years to < 18 years at the time of consent with clinical diagnosis of AD Subjects with a vIGA-AD™ score of ≥ 3 and AD covering ≥ 40% of the BSA at Screening and Baseline (pre-randomization), or subjects with a vIGA-AD™ score of 2 at Screening and Baseline (pre-randomization) regardless of BSA. Subjects must have screened for the DMVT-505-3101 or DMVT-505-3102 study and failed to meet BSA and/or vIGA-AD™ eligibility criteria. AD present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old Must not be pregnant at Screening or Baseline For All Subjects: Female subjects of childbearing potential who are engaging in sexual activity that could lead to pregnancy should use acceptable birth control methods Subject, subject's parent, or legal representative must be capable of giving written informed consent/assent Exclusion Criteria: For Rollover Subjects Only: Subjects who were not receiving study drug at the time of the last visit in the pivotal study (DMVT-505-3101, DMVT-505-3102, or DMVT-505-2104) Used a prohibited concomitant product or procedure to treat AD during the pivotal study. Had an SAE that was related to treatment or experienced an AE that led to permanent discontinuation of treatment in the pivotal study. Pregnant females For Direct-Enrolling Subjects: Immunocompromised at screening Chronic or acute systemic or superficial infection requiring treatment with systemic antibacterials or antifungals within one week prior to baseline visit Significant dermatological or inflammatory condition other than AD that, in the Investigator's opinion, would make it difficult to interpret data or assessments during the study Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.0x the upper limit of normal (ULN). Screening total bilirubin > 1.5x ULN Current or chronic history of liver disease Current or history of cancer within 5 years except for adequately treated cutaneous basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix Subjects who would not be considered suitable for topical therapy Use of any prohibited medication or procedure within the indicated period before the baseline visit including other investigational product within 30 days or 5 half-lives of the investigational product (whichever is longer) History of or ongoing serious illness or medical, physical, or psychiatric condition(s) that, in the Investigator's opinion, may interfere with the subject's participation in the study, interpretation of results, or ability to understand and give informed consent. Pregnant or lactating females History of sensitivity to the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation Previous known participation in a clinical study with tapinarof (previously known as GSK2894512 and WBI-1001)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Brown, MD, JD
Phone
480-666-0844
Email
dermavantclinicaltrials@dermavant.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana Villalobos
Organizational Affiliation
Dermavant Sciences, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Dermavant Clinical Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Bryant
State/Province
Arkansas
ZIP/Postal Code
72022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Fort Smith
State/Province
Arkansas
ZIP/Postal Code
72916
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Cerritos
State/Province
California
ZIP/Postal Code
90702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91320
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Margate
State/Province
Florida
ZIP/Postal Code
33063
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40517
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
Dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Largo
State/Province
Maryland
ZIP/Postal Code
20774
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Clarkston
State/Province
Michigan
ZIP/Postal Code
48346
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Bexley
State/Province
Ohio
ZIP/Postal Code
43209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Mayfield Heights
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29445
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Cypress
State/Province
Texas
ZIP/Postal Code
77433
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Dripping Springs
State/Province
Texas
ZIP/Postal Code
78620
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6J 7W5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2C 3N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 7G1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com
Facility Name
Dermavant Clinical Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dermavant Clinical Trials
Email
dermavantclinicaltrials@dermavant.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25613671
Citation
Basra MK, Salek MS, Camilleri L, Sturkey R, Finlay AY. Determining the minimal clinically important difference and responsiveness of the Dermatology Life Quality Index (DLQI): further data. Dermatology. 2015;230(1):27-33. doi: 10.1159/000365390. Epub 2015 Jan 20.
Results Reference
background
PubMed Identifier
18385500
Citation
Bieber T. Atopic dermatitis. N Engl J Med. 2008 Apr 3;358(14):1483-94. doi: 10.1056/NEJMra074081. No abstract available.
Results Reference
background
Citation
Cappon GD and Hurtt ME. Developmental toxicity of the kidney. In: Kapp RW and Yyl L, editors. Reproductive Toxicology, Target Organ Series, 3rd edition. New York Informa Healthcare, 2010:193-204.
Results Reference
background
Citation
Frazier KS and Seely JC. Urinary system. In: Sahota PS, Popp JA, Hardisty JF and Gopinath C, editors. Toxicologic Pathology: Nonclinical Safety Assessment. CRC Press, 2013:421-84
Results Reference
background
PubMed Identifier
15916563
Citation
Carroll CL, Balkrishnan R, Feldman SR, Fleischer AB Jr, Manuel JC. The burden of atopic dermatitis: impact on the patient, family, and society. Pediatr Dermatol. 2005 May-Jun;22(3):192-9. doi: 10.1111/j.1525-1470.2005.22303.x.
Results Reference
background
PubMed Identifier
31683543
Citation
Furue M, Hashimoto-Hachiya A, Tsuji G. Aryl Hydrocarbon Receptor in Atopic Dermatitis and Psoriasis. Int J Mol Sci. 2019 Oct 31;20(21):5424. doi: 10.3390/ijms20215424.
Results Reference
background
Citation
Hanifin JM, Rajka G. Diagnostic features of atopic dermatitis. Acta Dermato-Venereologica Supplementum. 1980;92:44-7.
Results Reference
background
PubMed Identifier
11168575
Citation
Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11-8. doi: 10.1034/j.1600-0625.2001.100102.x.
Results Reference
background
PubMed Identifier
16893440
Citation
Lewis-Jones S. Quality of life and childhood atopic dermatitis: the misery of living with childhood eczema. Int J Clin Pract. 2006 Aug;60(8):984-92. doi: 10.1111/j.1742-1241.2006.01047.x.
Results Reference
background
PubMed Identifier
28595996
Citation
Smith SH, Jayawickreme C, Rickard DJ, Nicodeme E, Bui T, Simmons C, Coquery CM, Neil J, Pryor WM, Mayhew D, Rajpal DK, Creech K, Furst S, Lee J, Wu D, Rastinejad F, Willson TM, Viviani F, Morris DC, Moore JT, Cote-Sierra J. Tapinarof Is a Natural AhR Agonist that Resolves Skin Inflammation in Mice and Humans. J Invest Dermatol. 2017 Oct;137(10):2110-2119. doi: 10.1016/j.jid.2017.05.004. Epub 2017 Jun 6.
Results Reference
background
PubMed Identifier
12866702
Citation
Zoetis T, Hurtt ME. Species comparison of anatomical and functional renal development. Birth Defects Res B Dev Reprod Toxicol. 2003 Apr;68(2):111-20. doi: 10.1002/bdrb.10013. No abstract available.
Results Reference
background

Learn more about this trial

Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis

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