A Breakthrough in Male Hair Loss Treatment: Clascoterone 5% Topical Solution Shows Impressive Phase III Results
- American Mane
- 1 day ago
- 2 min read
For millions of men around the world dealing with androgenetic alopecia, commonly known as male-pattern hair loss, a promising new treatment may soon become available. In December 2025, Cosmo Pharmaceuticals announced groundbreaking topline results from two large Phase III clinical trials evaluating clascoterone 5% topical solution, showing dramatic improvements in hair growth compared with placebo.
Credit: Adapted from the Cosmo Pharmaceuticals press release titled“Cosmo Announces Breakthrough Phase III Topline Results from Scalp 1 and Scalp 2 for Clascoterone 5% Solution in Male Hair Loss.”
What the Trials Revealed
The Phase III program, consisting of two identically designed studies known as Scalp 1 and Scalp 2, enrolled a total of 1,465 men across the United States and Europe. Participants used the clascoterone 5% solution over a six-month period.
The results were remarkable:
In one study, clascoterone demonstrated a 539% relative improvement in Target-Area Hair Count compared with placebo.
In the second study, the improvement reached 168% compared with placebo.
Both trials met their primary endpoints, showing statistically significant and clinically meaningful hair growth. Importantly, the treatment’s safety profile was similar to placebo.
A Novel Mechanism After 30 Years of Limited Innovation
What makes clascoterone 5% solution particularly exciting is its unique mechanism of action. Unlike oral treatments that affect hormones throughout the body, clascoterone acts locally at the hair follicle. It blocks the activity of dihydrotestosterone (DHT). The hormone is primarily responsible for follicle shrinkage, acting directly at the receptor with negligible systemic absorption.
Cosmo Pharmaceuticals notes that this represents the first major therapeutic innovation in male hair loss in more than three decades, offering new hope to those who have not responded well to existing options.
Safety and Patient Experience
Both Phase III studies found that treatment-emergent side effects were similar between the clascoterone and placebo groups. Most reported effects were mild and unrelated to the medication. Patient-reported outcomes also aligned with the objective findings:
One study showed statistically significant improvement in patient perception of hair growth.
The other displayed a consistent positive trend.
Overall, the drug appears to be well-tolerated with a positive user experience.
What Comes Next?
Cosmo Pharmaceuticals plans to move forward with regulatory submissions in both the United States and Europe once the full 12-month safety data becomes available, expected in spring 2026.
If approved, clascoterone 5% topical solution could dramatically transform the treatment landscape for androgenetic alopecia, offering a highly effective, targeted, and well-tolerated option for the millions of men seeking real hair-growth solutions.