A Phase 2, Randomized, Controlled, Dose-Ranging Study Evaluating Crisaborole Topical Ointment, 0.5% and 2% in Adolescents With Mild to Moderate Atopic Dermatitis.

Abstract

BACKGROUND:

Crisaborole is a novel, boron-based, small-molecule, topical phosphodiesterase-4 inhibitor in development for the treatment of patients with mild to moderate atopic dermatitis (AD).

METHODS:

In this multicenter, randomized, double-blind, dose-ranging, phase 2 study, adolescent patients 12 to 17 years of age with mild to moderate AD and 2 distinct target AD lesions were randomized to once-daily (QD) or twice-daily (BID) treatment with crisaborole topical ointment. For each patient, 2 target lesions were randomized to receive 29 days of treatment with 0.5% or 2% crisaborole topical ointment. The primary endpoint was change from baseline in AD severity index (ADSI) score for each lesion. Exploratory efficacy endpoints and safety were also assessed.

RESULTS:

A total of 86 patients were enrolled and received crisaborole topical ointment 0.5% or 2% QD (n=44) or BID (n=42). All dosing regimens produced dose-related improvements in ADSI as well as in all 5 component signs and symptoms of AD (erythema, excoriation, exudation, lichenification, and pruritus). The greatest improvements were consistently observed with crisaborole topical ointment, 2% applied BID. With this regimen, ADSI improved from baseline by 71%, and total or partial clearance of target lesions (ADSI ≤ 2) was achieved by 62% of patients after 29 days of treatment. Both doses of crisaborole topical ointment were well tolerated; mild application site reactions were the only treatment-related adverse events (QD, n=3; BID, n=1).

CONCLUSION:

These results provide preliminary evidence of the efficacy and safety of crisaborole topical ointment, 2% applied topically BID in adolescents with mild to moderate AD.

• Authors: Linda F Stein Gold, Lynda Spelman, Mary C Spellman, Matilda H Hughes, Lee T Zane
• Journal: Journal of drugs in dermatology : JDD (J Drugs Dermatol) Vol. 14 Issue 12 Pg. 1394-9 (Dec 2015) ISSN: 1545-9616 [Print] United States
• PMID: 26659931 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Boron Compounds
• Bridged Bicyclo Compounds, Heterocyclic
• Dermatologic Agents
• Immunosuppressive Agents
• Ointments
• crisaborole

Topics

• Administration, Topical
• Adolescent
• Boron Compounds (administration & dosage, adverse effects, therapeutic use)
• Bridged Bicyclo Compounds, Heterocyclic (administration & dosage, adverse effects, therapeutic use)
• Child
• Dermatitis, Atopic (drug therapy)
• Dermatologic Agents (administration & dosage, adverse effects, therapeutic use)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Endpoint Determination
• Female
• Humans
• Immunosuppressive Agents (therapeutic use)
• Male
• Ointments
• Treatment Outcome