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

• Status: Completed
• Trial end date: 2020-11-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovaderm Research Inc.

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.