What is Clascoterone?

Clascoterone is a novel topical anti-androgen drug that has been approved for the treatment of acne. Traditional oral anti-androgen therapies for acne, such as combined oral contraceptives and spironolactone, produce systemic hormonal effects and are generally not suitable for use in male patients, nor in some female patients. In contrast, Clascoterone is a first-in-class anti-androgen drug that has been shown to be both safe and effective in female and male patients over the age of 12. It is generally well tolerated except for occasional localised skin irritation, although in a Phase II clinical trial some adolescents showed biochemical evidence of HPA suppression, which disappeared after discontinuation of treatment.

Indications

Clascoterone is approved by the FDA for the topical treatment of acne vulgaris in patients 12 years of age and older. Clascoterone has also been found to be effective in treating androgenetic alopecia in male subjects (aged 18–55 years) with mild to moderate disease in the temple and vertex region. It has not received FDA approval for this indication yet.

Mechanisms of action

Clascoterone competes with androgens (especially dihydrotestosterone) for binding to the androgen receptor and restricts its binding, thereby inhibiting downstream signalling in the acne pathway. It inhibits androgen receptor-regulated gene transcription and antagonises the production of lipids and inflammatory cytokines in human primary sebocytes with a dose-dependent manner.

Side effects

Common side effects of Clascoterone include: dryness at the site of application, flaking, erythema, hirsutism, acne, pain, contact dermatitis, hair colour change, eye irritation, peri-abdominal abscess, dysphonia, headache, oropharyngeal pain and allergy at the site of application. Elevated potassium levels have been observed in some study subjects. Long-term safety studies have shown that the drug does not produce systemic antiandrogenic effects such as hypogonadism or feminisation in male subjects.

References:

[1] CYRIAC MANJALY. Clascoterone for treatment of acne.[J]. Drugs of today, 2023. DOI:10.1358/dot.2023.59.2.3507749.

[2] PARVATHY SANTHOSH MD; Mamatha G M. Clascoterone: a new topical anti-androgen for acne management[J]. International Journal of Dermatology, 2021. DOI:10.1111/ijd.15752.