- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02001181
Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)
September 16, 2015 updated by: Pfizer
A Phase 2a, Multi-site, Randomized, Double-blind, Vehicle-controlled, Parallel-group Study Of The Pilot Efficacy, Safety, Tolerability, And Pharmacokinetics Of 2% Tofacitinib Ointment In Subjects With Mild To Moderate Atopic Dermatitis
The study is being conducted to evaluate the efficacy, safety and tolerability of 2% tofacitinib ointment (20 mg/g) BID (twice daily) in subjects with mild to moderate atopic dermatitis compared to placebo (vehicle) BID for 4 weeks.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Quebec, Canada, G1V 4X7
- Centre de Recherche dermatologique du Quebec Metropolitain
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Ontario
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Peterborough, Ontario, Canada, K9J 1Z2
- Skin Centre For Dermatology
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Richmond Hill, Ontario, Canada, L4B 1A5
- The Centre for Dermatology
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Waterloo, Ontario, Canada, N2J 1C4
- K. Papp Clinical Research
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Quebec
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Montreal, Quebec, Canada, H2K 4L5
- Innovaderm Research Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a clinical diagnosis of atopic dermatitis (also known as atopic eczema) for at least 6 months prior to Day 1 that has been clinically stable for at least 1 month prior to Day 1 and is confirmed to be atopic dermatitis according to the criteria of Hanifin and Rajka.
- Have a PGA score of 2 (mild) or 3 (moderate) at Day 1.
- Have atopic dermatitis on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs including palms and soles covering at least 2% of total body surface area (BSA) and up to and including 20% of total BSA at Day 1. At least 2% of the total BSA will need to be on the head (including face, but excluding hair bearing scalp), neck, trunk (excluding groin and genitals), or limbs (excluding palms and soles).
Exclusion Criteria:
- Evidence of certain skin conditions/infections at baseline
- Currently have atopic dermatitis on groin, genitals, palm or soles
- Have certain laboratory abnormalities at baseline
- Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group A
|
Tofacitinib ointment 20mg/g twice daily (BID) for 4 weeks
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Placebo Comparator: Treatment B
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Placebo ointment (vehicle) twice daily (BID) for 4 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4
Time Frame: Baseline (pre-dose on Day 1) and Week 4
|
The EASI quantifies the severity of a participant's atopic dermatitis based on both lesion severity and the percent of BSA affected.
The EASI is a composite scoring by the atopic dermatitis clinical evaluator of the degree of erythema, induration/papulation, excoriation, and lichenification (each scored separately) for each of 4 body regions, with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body.
The EASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of atopic dermatitis.
What is reported is the percent change from baseline in EASI scores.
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Baseline (pre-dose on Day 1) and Week 4
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4
Time Frame: Week 4
|
The PGA score assesses the overall severity of atopic dermatitis.
Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate, and severe, respectively) based on morphological descriptors.
|
Week 4
|
Proportion of Participants With Response of Clear or Almost Clear and Greater Than or Equal to (>=) 2 Grade/Point Improvement From Baseline at Week 4
Time Frame: Baseline (pre-dose on Day 1) and Week 4
|
The PGA score assesses the overall severity of atopic dermatitis.
Scores range from 0 to 4 and correspond to a category (clear, almost clear, mild, moderate, and severe, respectively) based on morphological descriptors.
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Baseline (pre-dose on Day 1) and Week 4
|
Percent Change From Baseline in Body Surface Area (BSA) Efficacy at Week 4
Time Frame: Baseline (pre-dose on Day 1) and Week 4
|
The percent BSA with atopic dermatitis in a body region was determined by the number of handprints of atopic dermatitis skin in that region: head and neck, upper limbs, trunk including axillae, lower limbs including buttocks.
In the handprint method, the full palmar hand of the participant (i.e., the participant's fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA.
What is reported is the percent change from baseline in BSA affected.
|
Baseline (pre-dose on Day 1) and Week 4
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Change From Baseline in the EASI Clinical Signs Severity Sum Score at Week 4
Time Frame: Baseline (pre-dose on Day 1) and Week 4
|
The EASI Clinical Signs Severity Sum Score was derived from the EASI.
The Clinical Signs Severity Scores on the 4-point scale for dermatitis lesions were summed in each EASI body region.
The sum of the Clinical Signs Severity Score in each EASI body region was then totaled across the 4 EASI body regions to provide an EASI Clinical Signs Severity Sum Score, which ranged from 0 to 48, with higher scores representing greater severity of atopic dermatitis.
|
Baseline (pre-dose on Day 1) and Week 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
November 27, 2013
First Submitted That Met QC Criteria
November 27, 2013
First Posted (Estimate)
December 4, 2013
Study Record Updates
Last Update Posted (Estimate)
October 15, 2015
Last Update Submitted That Met QC Criteria
September 16, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A3921214
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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