Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02001181
First received: November 27, 2013
Last updated: September 16, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention Phase
Dermatitis, Atopic
Drug: Tofacitinib ointment 20mg/g
Drug: Placebo ointment (Vehicle)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 69
Study Start Date: December 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02001181

Locations
Canada, Ontario
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
Canada, Quebec
Innovaderm Research Inc.
Montreal, Quebec, Canada, H2K 4L5
Canada
Centre de Recherche Dermatologique du Quebec metropolitain
Quebec, Canada, G1V 4X7
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02001181     History of Changes
Other Study ID Numbers: A3921214 
Study First Received: November 27, 2013
Results First Received: September 16, 2015
Last Updated: September 16, 2015
Health Authority: Canada: Health Canada

Keywords provided by Pfizer:
Atopic Dermatitis
Atopic Eczema
Eczema
topical treatment
skin diseases
tofacitinib
CP-690
550
Janus Kinase inhibitor

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 27, 2016