Hair loss, especially androgenetic alopecia—widely recognised as male or female pattern baldness—brings significant emotional distress. It often begins subtly in one’s 20s or 30s and progresses over time, affecting self-confidence and quality of life.
Patients frequently approach me frustrated with the limited options available. They want to know if there is any treatment beyond the staples, such as minoxidil and finasteride. And recent advancements offer genuine hope. Clascoterone, a topical treatment originally developed for acne, is now demonstrating impressive potential for hair regrowth in pattern hair loss.
Already approved in a 1 per cent cream form (Winlevi) for acne, it functions as a topical androgen receptor inhibitor. Its action is particularly targeted: clascoterone competitively binds to androgen receptors in the skin and hair follicles, blocking the effects of dihydrotestosterone (DHT)—the primary hormone responsible for follicle miniaturisation in androgenetic alopecia.
Derived from testosterone, DHT shortens the hair growth cycle and causes follicles to produce thinner, shorter hairs until they eventually stop producing hair altogether. By inhibiting DHT’s action directly at the receptor level on the scalp, clascoterone interrupts this process locally, with minimal systemic absorption. And this localised approach degrades rapidly in the bloodstream, reducing the risk of widespread hormonal effects.
Clascoterone vs minoxidil
To truly appreciate the potential of clascoterone, it’s helpful to compare it to minoxidil. Available over-the-counter in 2 per cent and 5 per cent formulations, minoxidil was originally an oral antihypertensive drug discovered to promote hair growth as a side effect. Its exact mechanism for hair regrowth isn’t fully elucidated, but it primarily acts as a potassium channel opener, leading to vasodilation—increased blood flow to the hair follicles. This enhanced circulation delivers more oxygen and nutrients, potentially prolonging the growth phase of the hair cycle, enlarging miniaturised follicles, and stimulating dormant ones. Minoxidil also appears to influence growth factors such as vascular endothelial growth factor (VEGF) and may have anti-apoptotic effects on follicle cells.
However, minoxidil does not address the hormonal root cause of androgenetic alopecia. It supports hair growth but doesn’t block DHT or androgen signalling. As a result, many patients experience initial shedding and require twice-daily application indefinitely (discontinuation often leads to rapid hair loss). It’s dosage I have never recommended to anyone, as whenever it’s stopped, the results just disappear.
Many patients experience side effects such as scalp irritation, dryness, or unwanted facial hair growth. The efficacy varies; while minoxidil can increase hair density in about 40-60 per cent of users, results are often modest, and it works best in early-stage thinning. Interestingly, I only give minoxidil twice a week or maybe thrice a week even after I do a hair transplant.
Clascoterone, on the other hand, directly targets the pathophysiological driver of pattern baldness: androgen-mediated follicle damage. This makes it potentially more effective for hormone-sensitive cases and complementary to minoxidil, as the two could be combined for synergistic effects—one tackling hormones, the other enhancing follicle vitality. Early preclinical and phase 2 data even suggest clascoterone promotes dermal papilla cell activity and keratinocyte proliferation similarly to minoxidil, but through a distinct pathway. This is quite exciting.
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Promising results
The latest evidence underscoring clascoterone’s promise comes from December 2025 topline results of two large, identical phase 3 trials (SCALP-1 and SCALP-2) conducted by Cosmo Pharmaceuticals. These studies enrolled over 1,465 men with androgenetic alopecia across the US and Europe—the largest phase 3 programme ever for a topical hair loss treatment. Participants applied a 5 per cent clascoterone solution twice daily to the scalp for six months. Both trials achieved statistically significant improvements in target-area hair count (TAHC), with one study showing a remarkable 539 per cent relative improvement over placebo and the other 168 per cent. Patients also reported subjective benefits, such as visible growth and increased satisfaction. Crucially, the safety profile mirrored placebo, with no detectable systemic hormonal changes—highlighting its advantage over oral anti-androgens like finasteride, which can cause sexual side effects in some users.
Clascoterone is groundbreaking as potentially the first novel topical mechanism for androgenetic alopecia in over three decades. It addresses a major unmet need for patients intolerant to oral medications or seeking non-systemic options. Women with pattern thinning may also benefit in the future, though current phase 3 data focus on men; earlier studies showed promise in females.
It is important to remember that while it is promising, clascoterone is not a panacea for all hair loss. It is designed for hormonal pattern thinning in early to moderate stages and won’t help conditions like telogen effluvium (stress-related shedding), nutritional deficiencies, alopecia areata (autoimmune), or scarring alopecias. Accurate diagnosis—often involving trichoscopy, history, and sometimes blood tests—is essential to determine suitability.
The 5 per cent formulation for hair loss awaits regulatory approval. Cosmo is completing 12-month safety follow-ups, with the FDA and EMA submissions planned for 2026. Until the drug becomes available, evidence-based options like minoxidil, finasteride (for suitable candidates), or low-level laser therapy remain frontline treatments.
Science is advancing rapidly, offering safer, more targeted solutions for healthier hair. If you’re noticing thinning, consult a dermatologist early. And most importantly, never self-medicate.
Dr Deepali Bhardwaj is a Consultant Dermatologist, Max Hospital, Saket. She is also an anti-allergy specialist, laser surgeon and internationally trained aesthetician. She tweets @dermatdoc. Views are personal.
(Edited by Prasanna Bachchhav)