Different Application Rates of Crisaborole Ointment 2% in Adults With Mild to Moderate Atopic Dermatitis

NCT ID: NCT03868098

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-21
• Study Completion Date: 2020-11-25

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.

Conditions

Dermatitis, Atopic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Crisaborole 2% (application rate A, B, C)

Crisaborole (Marketed drug)

Group Type: ACTIVE_COMPARATOR

Crisaborole 2%

Intervention Type: DRUG

Crisaborole ointment 2% (application rate A, B, C) for 15 days (double blind)

Placebo ointment (vehicle)

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo ointment

Intervention Type: DRUG

Placebo ointment (vehicle)

Interventions

Crisaborole 2%

Crisaborole ointment 2% (application rate A, B, C) for 15 days (double blind)

Intervention Type: DRUG

Placebo ointment

Placebo ointment (vehicle)

Intervention Type: DRUG

Other Intervention Names

Eucrisa

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovaderm Research Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Bissonnette, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Director

Locations

Innovaderm Research Inc.

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

Inno-6049

Identifier Type: -

Identifier Source: org_study_id