Clinical trial NCT02001181: Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dermatitis, Atopic
Keywords: Atopic Dermatitis
Atopic Eczema
Eczema
topical treatment
skin diseases
tofacitinib
CP-690
550
Janus Kinase inhibitor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-12-04
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 4
timeFrame: Baseline (pre-dose on Day 1) and Week 4
Secondary outcomes:
measure: Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear at Week 4
timeFrame: Week 4
measure: 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
timeFrame: Baseline (pre-dose on Day 1) and Week 4
measure: Percent Change From Baseline in Body Surface Area (BSA) Efficacy at Week 4
timeFrame: Baseline (pre-dose on Day 1) and Week 4
measure: Change From Baseline in the EASI Clinical Signs Severity Sum Score at Week 4
timeFrame: Baseline (pre-dose on Day 1) and Week 4
Other outcomes:
Locations:
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Purohit VS, Ports WC, Wang C, Riley S. Systemic Tofacitinib Concentrations in Adult Patients With Atopic Dermatitis Treated With 2% Tofacitinib Ointment and Application to Pediatric Study Planning. J Clin Pharmacol. 2019 Jun;59(6):811-820. doi: 10.1002/jcph.1360. Epub 2018 Dec 17.