Trial record 2 of 92 for:    Open Studies | "Dermatitis, Atopic"

Tofacitinib Ointment For Atopic Dermatitis (Atopic Eczema)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02001181
First received: November 27, 2013
Last updated: August 12, 2014
Last verified: August 2014
  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:
  • Eczema Area and Severity Index (EASI) [ Time Frame: baseline, Week 4 ] [ Designated as safety issue: No ]
    percent change from baseline at week 4


Secondary Outcome Measures:
  • Physician Global Assessment (PGA) of Disease Activity [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    proportion of subjects with PGA response of

  • Body surface ares (BSA) [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    percent change from baseline in BSA at week 4

  • Eczema area and severity index (EASI) clinical sign severity sum score [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    Change from baseline in the EASI clinical sign severity sum score at week 4


Estimated Enrollment: 70
Study Start Date: December 2013
Estimated Study Completion Date: September 2014
Estimated 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
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

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Canada, Ontario
SKiN Centre for Dermatology Recruiting
Peterborough, Ontario, Canada, K9J 1Z2
The Centre for Dermatology & Cosmetic Recruiting
Richmond Hill, Ontario, Canada, L4B 1A5
K. Papp Clinical Research Recruiting
Waterloo, Ontario, Canada, N2J 1C4
Canada, Quebec
Innovaderm Research Inc. Recruiting
Montreal, Quebec, Canada, H2K 4L5
Canada
Centre de Recherche de Dermatologique du Quebec metropolitain Recruiting
Quebec, Canada, G1V 4X7
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02001181     History of Changes
Other Study ID Numbers: A3921214
Study First Received: November 27, 2013
Last Updated: August 12, 2014
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, Atopic
Dermatitis
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014