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Crisaborole and Atopic Dermatitis Skin Biomarkers: An Intrapatient Randomized Trial

Crisaborole and Atopic Dermatitis Skin Biomarkers: An Intrapatient Randomized Trial

Robert Bissonnette, Ana B Pavel, Aisleen Diaz, John L Werth, Chuanbo Zang, Ivana Vranic, Vivek S Purohit, Michael A Zielinski, Bonnie Vlahos, Yeriel D Estrada, Etienne Saint-Cyr Proulx, William C Ports, etc.

J Allergy Clin Immunol. 2019 Nov;144(5):1274-1289.

PMID: 31419544

Abstract:

Background:
Crisaborole ointment 2% is a nonsteroidal phosphodiesterase 4 inhibitor for the treatment of mild-to-moderate atopic dermatitis (AD). The mechanism of action of crisaborole and its effects on lesional measures of disease severity are not yet well defined.
Objective:
This phase 2a, single-center, vehicle-controlled, intrapatient study was designed to further characterize the mechanism of action of crisaborole through evaluation of clinical efficacy and changes in skin biomarkers in adults (n = 40) with mild-to-moderate AD.
Methods:
Two target lesions were randomized in an intrapatient (1:1) manner to double-blind crisaborole/vehicle applied twice daily for 14 days. Patients then applied crisaborole (open-label) to all affected areas for 28 days. Punch biopsy specimens were collected for biomarker analysis at baseline, day 8 (optional), and day 15.
Results:
Crisaborole treatment resulted in early improvement in lesional signs/symptoms versus vehicle, with improvement in pruritus (pruritus numeric rating scale) observed as early as 24 hours after the first application. Crisaborole-treated lesions showed significant percentage improvement from baseline in lesional transcriptomic profile compared with vehicle at day 8 (91.15% vs 36.02%, P < 10-15) that was sustained until day 15 (92.90% vs 49.59%, P < 10-15). Crisaborole significantly modulated key AD biomarkers versus vehicle, including TH2 and TH17/TH22 pathways and epidermal hyperplasia/proliferation. Molecular profiles and epidermal pathology normalized toward nonlesional skin and correlated with clinical changes in lesion severity and barrier function.
Conclusion:
Crisaborole reversed biomarker profiles of skin inflammation and barrier function, with associated improvements in clinical efficacy measures, highlighting the therapeutic utility of targeting phosphodiesterase 4 in patients with AD.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP906673243	Crisaborole		906673-24-3	Price

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