Clinical trial NCT03868098: Different Application Rates of Crisaborole Ointment 2% in Adults With Mild to Moderate Atopic Dermatitis
Official title: A Randomized, Double-Blind, Intra-Individual, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of Different Application Rates of Topically Applied Crisaborole Ointment 2% in Adult Subjects With Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dermatitis, Atopic
Lead sponsor: Innovaderm Research Inc.
Sponsor class: OTHER
First posted: 2019-03-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intra-individual
Primary purpose: TREATMENT

Brief summary: This study is being conducted to evaluate the efficacy and safety of 3 different application rates of topically applied Crisaborole ointment 2% over vehicle in adults with mild to moderate atopic dermatitis (AD). In each subject four application areas will be identified. Each subject will receive 4 treatments: the 3 different application rates of the active treatment and the vehicle. The areas will be randomly assigned to treatment with topical Crisaborole ointment 2% and vehicle, once daily, for 2 weeks, without occlusion.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of active atopic dermatitis (AD) with at least 6 month history prior to screening and that has been clinically stable for 1 month.
* Has four application areas of 3 cm in diameter with a TSS of ≥5 and TAA of moderate at Day 1. The application areas must not be located on the face, scalp, axillae, groin, genitals, hands, and feet. The application areas should be ≥1 cm apart.

Exclusion Criteria:

* Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
* Subject has clinically infected AD.
* Subject has a Fitzpatrick's Skin Phototype ≥5.
* Subject is known to have immune deficiency or is immunocompromised.
* Subject has a history of cancer or lymphoproliferative disease within 5 years prior to Day 1. Subjects with successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or successfully treated localized carcinoma in situ of the cervix are not to be excluded.
* Subject had a major surgery within 8 weeks prior to Day 1 or has a major surgery planned during the study.
* Subject has any clinically significant medical condition that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.
* Subject has a known history of chronic infectious disease (eg, hepatitis B, hepatitis C, or infection with human immunodeficiency virus).
* Subject with a known lack of efficacy to crisaborole.
* Subject has a known or suspected allergy to crisaborole, including any non-medicinal ingredient, or component of the container.
* Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.

Primary outcomes:
measure: Total Signs Score (TSS)
timeFrame: Baseline, Day 15
Secondary outcomes:
measure: Total Signs Score (TSS)
timeFrame: Baseline, Day 8, Day 15
measure: Target Area Assessment (TAA)
timeFrame: Change from baseline in TAA at Day 8 and Day 15.
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
Study officials:
affiliation: Medical Director
name: Robert Bissonnette, MD
role: PRINCIPAL_INVESTIGATOR
References: