Active and vehicle control study of Crisaborole in Atopic Dermatitis
Research type
Research Study
Full title
A PHASE 3B/4, MULTICENTER, RANDOMIZED, ASSESSOR BLINDED, VEHICLE AND ACTIVE (TOPICAL CORTICOSTEROID AND CALCINEURIN INHIBITOR) CONTROLLED, PARALLEL GROUP STUDY OF THE EFFICACY, SAFETY, AND LOCAL TOLERABILITY OF CRISABOROLE OINTMENT, 2% IN PEDIATRIC AND ADULT SUBJECTS (AGES 2 YEARS AND OLDER) WITH MILD TO MODERATE ATOPIC DERMATITIS
IRAS ID
248453
Contact name
Bonnie Vlahos
Contact email
Sponsor organisation
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eudract number
2018-001043-31
Clinicaltrials.gov Identifier
77 537, US IND
Duration of Study in the UK
1 years, 5 months, 13 days
Research summary
The purpose of this clinical research study is to evaluate the safety and effectiveness of an ointment containing the investigational drug crisaborole in children (over the age of 2) and adults with mild to moderate atopic dermatitis. In addition, crisaborole will be compared with two other commonly prescribed topical medicines, either hydrocortisone butyrate or pimecrolimus. Patients will be randomly assigned by chance (like flipping a coin) to receive crisaborole, placebo (dummy drug), hydrocortisone or pimecrolimus. Neither the participant nor the study doctor will know which of these you are assigned to.
This research study will be conducted in approximately 36 hospitals in 9 countries. About 600 patients will be enrolled into this study which will last for about 3 months. Patients with mild to moderate atopic dermatitis will be screened and then if eligible will be randomly assigned to a study treatment where they will be asked to apply the treatment to specific skin areas on their body affected by atopic dermatitis twice a day for 28 days. The study doctor will monitor their condition during weekly study visits, and will ask patients to keep a study diary. The diary will record study treatment doses that have been applied and atopic dermatitis symptoms (for example, itching). Patients will be asked to visit the research site at least six times during the study, and will need to be available for two follow up telephone calls.
REC name
East of England - Essex Research Ethics Committee
REC reference
19/EE/0016
Date of REC Opinion
15 Feb 2019
REC opinion
Further Information Favourable Opinion