Topical Clascoterone has been making the news lately as potentially being a first-in-class medication for the treatment of androgenetic alopecia. First-in-class means it uses a different mechanism of action than the other FDA-approved hair loss treatment options. If approved, it will be the first new therapeutic mechanism for androgenetic alopecia, the most common form of hair loss, in almost 30 years. Currently, the only FDA-approved treatments for androgenetic alopecia are oral finasteride (approved in 1997) and topical minoxidil (approved in 1988).
In this article, we’ll explore whether there will be a future role for topical Clascoterone in the treatment of androgenetic alopecia.
What is Clascoterone?
Clascoterone was first FDA-approved as a topical 1% cream for the treatment of Acne Vulgaris in both men and women 12 years of age or older in 2020. It is sold under the brand name of Winlevi by Cosmo Pharmaceuticals.
A 5% solution is presently in FDA Trials for the treatment of Androgenetic Alopecia.
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How does 5% Clascoterone Solution work?
5% Clascoterone solution is an antiandrogen medication that targets testosterone and dihydrotestosterone (DHT) receptors in the skin and hair follicles. It is well known that DHT is the causative hormone involved in the miniaturization process of the hair shaft seen in the susceptible hair follicles of androgenetic alopecia. Therefore, it makes logical sense that by blocking the DHT receptors, there would be a slowing of the progressive miniaturization seen as a patient ages. Studies have shown that there is minimal systemic absorption when Clascoterone is applied to the skin.
5% Clascoterone Solution Study Results
Phase 3 Trial Findings
- Two identical studies involved 1,465 Male patients over the age of 18 years old.
- The 6-month studies were multicenter, randomized, double-blind vehicle-controlled trials in the United States and Europe.
- The two studies showed robust, statistically significant (p<0.05), and clinically meaningful improvements with a safety and tolerability profile comparable to the placebo vehicle. One study demonstrated a 5.39x (539 percent) relative improvement in Target-Area Hair Count (TAHC) versus vehicle, while the second study showed a 1.68x (168 percent) relative improvement.[1]
- The other endpoint was Patient-Reported Outcome (PRO) (i.e, did the patient feel there was an improvement), which reinforced the TAHC results.
- In summary, these Phase 3 trials showed significant improvement in hair thickness and positive patient-reported outcomes.
Side Effects of Clascoterone
- The effects of local skin irritation were similar to those of the placebo group.
- Suppression of the hypothalamic–pituitary–adrenal axis (HPA axis) may occur during Clascoterone therapy in some individuals. HPA axis function returned to normal within 4 weeks following discontinuation of Clascoterone.[2]
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When will Clascoterone be Available for Hair Loss Treatment?
Cosmo Pharmaceuticals plans to complete the required 12-month safety follow-up by spring 2026, and then promptly submit for governmental approval in men with androgenetic alopecia. Clascoterone 5% topical solution will be the first-in-class topical anti-androgen solution for the treatment of androgenetic alopecia in men.
Will Topical 5% Clascoterone solution be approved for use in women with androgenetic alopecia?
- Not at present for women.
- The current studies were only performed on men.
My Opinion
We currently do not have a silver bullet to treat androgenetic alopecia.
Presently, there are only two FDA-approved medications in the treatment of androgenetic alopecia (the most common form of hair loss), oral Propecia (finasteride) and Rogaine (topical minoxidil). As Dermatologists (the medical experts for hair loss & hair restoration), we’re always looking for better treatments for androgenetic alopecia since we have no perfect treatment for this hair loss aging process. For now, the best-validated FDA-approved treatments for male/female pattern hair loss are the medical therapies finasteride and minoxidil, or surgical options like hair transplantation performed by qualified hair transplant physicians.
Unfortunately, since there is no perfect treatment now, it creates the perfect environment for “snake-oil miracle-cure” products, which have been abundant over the last several decades. I believe it is imperative to keep an open, but skeptical, mind to new treatments for hair loss. I believe Topical 5% Clascoterone solution holds significant promise, and I’m eagerly awaiting the 12-month safety study data. I do not believe it will be a silver bullet in the treatment of androgenetic alopecia, but I do believe it will become a valuable and significant tool for Dermatologists treating androgenetic alopecia in men (and hopefully, eventually, women).
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Sources
1. https://www.cosmopharma.com/news/cosmo-announces-breakthrough-phase-iii-topline-results-from-scalp-1-and-scalp-2-for-clascoterone-5-solution-in-male-hair-loss-showing-up-to-539-relative-improvement-in-target-area-hair-count-vs-place
2. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673a84b-7f5c-47ab-a99c-1e3db21a6a09
Dr. Paul J. McAndrews is a world-renowned expert in hair loss and hair restoration, and one of only two physicians to have served as President of both the ISHRS and ABHRS. He is a Clinical Professor at USC/LAC Medical Center and an Expert Medical Reviewer for the California Medical Board. Known for his artistic, patient-focused approach, Dr. McAndrews performs one hair transplant per day to ensure exceptional, individualized results.