Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)
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|ClinicalTrials.gov Identifier: NCT02001181|
Recruitment Status : Completed
First Posted : December 4, 2013
Results First Posted : October 15, 2015
Last Update Posted : October 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Dermatitis, Atopic||Drug: Tofacitinib ointment 20mg/g Drug: Placebo ointment (Vehicle)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
|Experimental: Treatment group A||
Drug: Tofacitinib ointment 20mg/g
Tofacitinib ointment 20mg/g twice daily (BID) for 4 weeks
|Placebo Comparator: Treatment B||
Drug: Placebo ointment (Vehicle)
Placebo ointment (vehicle) twice daily (BID) for 4 weeks
- 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001181
|SKiN Centre for Dermatology|
|Peterborough, Ontario, Canada, K9J 1Z2|
|The Centre for Dermatology|
|Richmond Hill, Ontario, Canada, L4B 1A5|
|K. Papp Clinical Research|
|Waterloo, Ontario, Canada, N2J 1C4|
|Innovaderm Research Inc.|
|Montreal, Quebec, Canada, H2K 4L5|
|Centre de Recherche Dermatologique du Quebec metropolitain|
|Quebec, Canada, G1V 4X7|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|