Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2018-05-04

Brief Summary

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This study is being conducted to characterize the mechanism of action of crisaborole ointment 2%, by evaluation of efficacy and changes in key skin biomarkers in atopic dermatitis (AD) lesions treated with crisaborole ointment 2% over vehicle, in subjects with mild to moderate AD. Two identified AD skin lesions for each subject will be treated for the first 15 days, one with crisaborole ointment 2% and one with vehicle, in a blinded manner, and biopsies for biomarker analysis will be performed on the lesions. Following completion of the blinded treatment period, subjects will start the 28 day open label period during which all AD affected skin lesions will be treated with crisaborole ointment 2% twice daily.

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Detailed Description

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Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Crisaborole ointment

Group Type EXPERIMENTAL

Crisaborole ointment 2% BID

Intervention Type DRUG

Crisaborole ointment 2% BID for 15 days (double blind); additional 28 days (open label)

Placebo ointment (vehicle)

Group Type PLACEBO_COMPARATOR

Placebo ointment (vehicle)

Intervention Type DRUG

Placebo ointment (vehicle) BID for 15 days (double blind)

Interventions

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Crisaborole ointment 2% BID

Crisaborole ointment 2% BID for 15 days (double blind); additional 28 days (open label)

Intervention Type DRUG

Placebo ointment (vehicle)

Placebo ointment (vehicle) BID for 15 days (double blind)

Intervention Type DRUG

Eligibility Criteria

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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.
* Investigator's Static Global Assessment (ISGA) of 2 (mild) or 3 (moderate) at Baseline.
* Body surface area (BSA) covered with AD of at least 0.5% and no more than 10% at Baseline, calculation excluding face, scalp, axilla, genitals, groin area, palms, back of the hands, and soles.
* Two lesions of AD at least 3 cm x 3 cm in size and at least 5 cm apart, with identical Lesion ISGA score of greater than/equal to 3.

Exclusion Criteria

* Clinically infected AD or requires high potency topical corticosteroids or systemic (oral/injectable) corticosteroids to manage AD.
* History of angioedema or anaphylaxis to topical products or known sensitivity to components of crisaborole ointment 2%.
* History of cancer (except squamous or basal cell carcinoma or carcinoma in situ of the skin).
* Previous treatment with any topical or systemic PDE4 inhibitor unless stopped for the reason of lack of efficacy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No