Men experiencing hair loss may have a new option on the horizon: a topical treatment showing a 168 to 539 percent increase in hair count compared to a placebo. The results come from a phase 3 study involving nearly 1,500 men across the U.S. and Europe.
Could Clascoterone Be the Next Breakthrough in Hair Regrowth?
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A new study suggests significant hair growth improvements with a novel treatment, but experts urge caution.
- A phase 3 clinical trial demonstrated substantial hair growth with clascoterone.
- The treatment works by blocking androgen receptors in the skin, potentially reducing inflammation and sebum production.
- Experts caution that the treatment is most effective when hair loss is not advanced and requires long-term use.
- The cost of treatment is expected to be substantial, potentially several hundred euros per month.
The active ingredient, clascoterone, is applied as a solution or cream and targets a key factor in hereditary hair loss. “To answer this question, you have to understand what’s behind alopecia, or hereditary hair loss,” explains Markus Zeitlinger, a clinical pharmacologist at the Medical University of Vienna. “Alopecia occurs when the hair follicles are hypersensitive to androgens, i.e. male sex hormones such as testosterone – and more rarely when the androgen level is very high.”
Markus Zeitlinger, clinical pharmacologist at the Medical University of Vienna. Stanislav Kogiku
How Does Clascoterone Work?
Clascoterone blocks androgen receptors in the skin, potentially reducing sebum production and inflammation. Zeitlinger explains that inflammation causes hair follicles to shrink. “Then nothing grows back because the follicle slowly dies,” he says. “This process cannot be reversed in the final stage.” Therefore, early intervention is key. “If you have a mirror-smooth bald head, it’s definitely too late,” Zeitlinger cautions, noting the strongest effects are expected in areas where follicles haven’t completely disappeared.
From Acne Treatment to Hair Loss Solution
Interestingly, clascoterone is already approved under the brand name Winlevi as a topical treatment for acne, receiving approval from the European Medicines Agency in October and the U.S. Food and Drug Administration in 2020. During its development for acne, researchers observed increased hair growth as a side effect, prompting further investigation into its potential for treating hair loss at a five times higher dose.
Potential Side Effects and Cost
The phase 3 study reported no side effects, but Zeitlinger points out that local irritation, hormonal changes, and hyperkalemia (high potassium levels) have been observed in individuals using the drug for acne. “If these side effects occur at low doses, it can be assumed that they will also occur at higher doses,” he states. “There are no medications without side effects anyway. Because then they wouldn’t have any main effect.”
Zeitlinger tempers expectations, stating, “Even if you can definitely make a business with it, Clascoterone is not a game changer or a miracle cure for me.” He notes the study only presented percentages, which can be misleading. A 100 percent increase in a small number of hairs may not be dramatically visible.
The study measured both the increase in hair count per square centimeter and subjective/expert assessments of hair growth. Significant improvements in both assessments were seen in participants with nearly a 500 percent increase in hair, but less so in those with around a 170 percent increase. “That is suspicious, because even a 170 percent increase should actually be clearly visible,” Zeitlinger says. “This suggests that the absolute effects are small.”
The treatment requires consistent, twice-daily application for approximately six months, and would likely need to be continued indefinitely to maintain results. Hereditary hair loss is not curable, only manageable.
What’s Next?
Zeitlinger anticipates further study details and a potential application for approval from the European Medicines Agency in 2026. Given the observed effects and relatively few side effects, approval is considered likely.
The cost is a significant factor. A 60-gram tube of Winlevi currently costs around 550 euros. Zeitlinger estimates a hair loss treatment would likely be similarly priced, potentially costing several hundred euros per month.
Existing Treatments
Currently, minoxidil, a solution applied to the scalp, and finasteride, an oral medication, are common treatments for hair loss. Finasteride blocks the conversion of testosterone to dihydrotestosterone (DHT), which is linked to hair loss and prostate enlargement, but can cause side effects like erectile dysfunction. These options are significantly cheaper than clascoterone is expected to be. Zeitlinger believes using Winlevi at a high dose would likely have some effect, but wouldn’t be as cost-effective as minoxidil or finasteride.
