Clascoterone cream (1%) topical androgen receptor inhibitor for the treatment of acne in patients 12 years and older

ABSTRACT

Introduction

The efficacy of clascoterone cream was demonstrated in two phase three vehicle-controlled clinical trials that enrolled over 1,400 subjects. Its safety profile allowed it to be approved for treating patients as young as 12 years old. During clinical trials, the occurrence of local skin reactions (edema, erythema, pruritus, dryness) was similar to treatment with vehicle alone.

Areas covered

All publications describing the clinical development of clascoterone cream (cortexolone 17α-propionate) are reviewed and discussed in relation to with existing topical and systemic therapies for acne vulgaris.

Expert opinion

Clascoterone 1% cream is a novel first-in-class topical androgen receptor inhibitor for the treatment of acne vulgaris. Topical clascoterone 1% cream represents the first new type of therapy for acne treatment in almost 40 years and may become first-line therapy.

KEYWORDS:

• Clascoterone
• cortexolone 17α-propionate
• acne vulgaris
• clinical development

Article highlights

• Acne vulgaris is a chronic inflammatory dermatosis of the face and torso and one of the most prevalent skin diseases, affecting nearly 10% of the global population.

• Androgens are hormones that regulate sebum production and play a key role in acne pathogenesis, contributing to symptom onset and persistence.

• Clascoterone (cortexolone 17α-propionate) is a novel topical androgen receptor inhibitor, recently approved for the treatment of acne vulgaris in patients 12 years of age or older.

• Subjects in two 12-week phase 3, double-blind, controlled studies achieved significant improvements in baseline noninflammatory and inflammatory lesion counts.

• The safety of topical clascoterone was demonstrated in a large 9-month extension study.

• The results of a comparative study showed topical clascoterone was clinically superior to topical tretinoin for treating mild-to-moderate acne vulgaris.

Acknowledgments

The author acknowledges the editorial assistance of Dr Carl S. Hornfeldt, Apothekon, Inc., during the preparation of this manuscript with funding provided by Cassiopea, Inc.

Declaration of interest

Dr. Gold is a consultant and performs clinical research for Cassiopea SpA. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

One peer reviewer is an employee of Cassiopea Inc. Peer reviewers on this manuscript have no other relevant financial or other relationships to disclose.

Company review

Cassiopea provided a scientific accuracy review at the request of the journal editor.

Additional information

Funding

This manuscript was supported by Cassiopea Inc.