Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis

Summary

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.

Timeline

Start

2017-07-31

Primary completion

2018-05-04

Completion

2018-05-04

Outcome

Mixed primary results

registry analysis (superiority test); Crisaborole Ointment 2% Treated Lesion vs Vehicle Treated Lesion; p <0.0001; Least Squares Mean Difference -2.4 NCT03233529 ↗

registry analysis (superiority test); Crisaborole Ointment 2% Treated Lesion vs Vehicle Treated Lesion; p = 0.0420; Least Squares Mean Difference -0.9906 NCT03233529 ↗

registry analysis (superiority test); Crisaborole Ointment 2% Treated Lesion vs Vehicle Treated Lesion; p = 0.1519; Least Squares Mean Difference -0.5446 NCT03233529 ↗

registry analysis (superiority test); Crisaborole Ointment 2% Treated Lesion vs Vehicle Treated Lesion; p = 0.0007; Least Squares Mean Difference -1.1273 NCT03233529 ↗

registry analysis (superiority test); Crisaborole Ointment 2% Treated Lesion vs Vehicle Treated Lesion; p = 0.0871; Least Squares Mean Difference -0.7612 NCT03233529 ↗

registry analysis (superiority test); Crisaborole Ointment 2% Treated Lesion vs Vehicle Treated Lesion; p = 0.0055; Least Squares Mean Difference -1.3641 NCT03233529 ↗

registry analysis (superiority test); Crisaborole Ointment 2% Treated Lesion vs Vehicle Treated Lesion; p = 0.0238; Least Squares Mean Difference -1.1246 NCT03233529 ↗

registry analysis (superiority test); Crisaborole Ointment 2% Treated Lesion vs Vehicle Treated Lesion; p = 0.0042; Least Squares Mean Difference -1.9913 NCT03233529 ↗

Publications

• Bissonnette R, Pavel AB, Diaz A, Werth JL, Zang C, Vranic I, Purohit VS, Zielinski MA, Vlahos B, Estrada YD, Saint-Cyr Proulx E, Ports WC, Guttman-Yassky E. Crisaborole and atopic dermatitis skin biomarkers: An intrapatient randomized trial. J Allergy Clin Immunol. 2019 Nov;144(5):1274-1289. doi: 10.1016/j.jaci.2019.06.047. Epub 2019 Aug 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Crisaborole	Small molecule	2 %	Topical

Indications