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Clascoterone for Hair Regrowth

Created on 10/29/2026 – Quick Reference based on Evidence Review created using AI4L / Opus 5.5 – Audit

Clascoterone, a prescription medication that blocks male-hormone action where applied to the skin, is sold as an acne cream and developed as a scalp solution for pattern hair loss. In men, developer-run trials found more hair than an inactive solution; gains faded after stopping; absolute gains are unpublished. A trial in women found no gain. Risks, mostly from the cream, include skin irritation; animal studies point to harm in pregnancy. (Full Review)

Protocol

Phase 3 regimen
1.5 mL of 5% solution, twice daily
To the balding crown and temples; the SCALP 1 and 2 dose
Time of day
Morning and evening
At least 8 hours apart, as specified for the cream, onto a dry scalp
Off-label cream
Winlevi 1%, about 1 g twice daily
Labeled for acne; scalp use for hair is untested and one-fifth the trial concentration
Time to effect
Hair-count gains
From month 3
Continued to month 12 with ongoing use
Fair assessment
6–12 months
Of hair regrowth
Fewer acne lesions
12 weeks
Treatment success with the 1% facial cream in phase 3 trials

Benefits

Contraindications
  • Pregnancy, or possible pregnancy without contraception
  • Children under 12 years
  • Damaged scalp (cuts, abrasions, eczema, sunburn)
  • Adrenal insufficiency or long-term corticosteroid use
  • Hyperkalemia or advanced chronic kidney disease
  • Breastfeeding
    •
Key Interactions
  • Occlusion, large areas and prolonged use
  • Irritating topical products (medicated or abrasive cleansers, astringents)
    •
Theoretical (inferred from mechanism)
  • Corticosteroids, topical or systemic (hydrocortisone, prednisone)
  • Potassium-raising drugs (spironolactone, ACE inhibitors, angiotensin receptor blockers, trimethoprim)
  • Other androgen blockers (finasteride, dutasteride)
  • Topical minoxidil (over the counter)
  • Potassium supplements and potassium-based salt substitutes
  • Saw palmetto, pumpkin seed oil and other supplements marketed as DHT blockers
  • Testosterone therapy or anabolic steroids
    •

Risk & Side Effects

  • High:
  • Medium:
  • Low: Hypothalamic-pituitary-adrenal axis suppression; Elevated blood potassium; Application-site reactions; Sexual and systemic antiandrogen effects; Menstrual and ovarian effects in women
    •
  • Speculative: Fetal harm from exposure in pregnancy
    •

Monitoring

Marker Target Why
Serum potassium 3.5–5.0 mmol/L Safety check for high blood potassium
Cortisol 30 minutes after cosyntropin Above 18 µg/dL Safety check for adrenal suppression
Morning serum cortisol About 5–25 µg/dL Adrenal baseline when at risk
Serum creatinine Not specified in the ER Kidney function, paired with potassium
Target-area hair count No established target; change from own baseline The trials' primary endpoint
Global scalp photographs No established target; compare with own baseline Visible coverage
Pregnancy test Not specified in the ER Baseline in women

Cadence: Baseline potassium, photographs and hair count; potassium at 4–8 weeks, then every 6–12 months; photographs and hair counts at 3, 6 and 12 months, then yearly; cortisol testing only with symptoms or added corticosteroids.

Qualitative Assessment

  • Perceived density and scalp coverage, rated on a simple 7-point scale
  • Shedding seen in the shower or on brushes
  • Scalp itching, burning, redness or flaking
  • Libido, erectile function and breast tenderness
  • Menstrual regularity in women
  • Unusual fatigue, dizziness or salt craving, possible signs of low cortisol
Not medical advice. Educational distillation of a single evidence review. Confirm any decision with a qualified clinician, especially in the presence of prescription drugs or chronic conditions.