Acne is one of the most common complaints new members bring to ExcelMale. A man moves his total testosterone from 350 to 900 ng/dL, his DHT rises along with it, and within six to eight weeks his shoulders and upper back break out. The usual hormonal fixes, finasteride and spironolactone, work by cutting androgen signaling throughout the body. That undoes part of the reason he started TRT, and it is why most men refuse them.
Clascoterone changes that math. It blocks the androgen receptor only where you apply it, and the dose that gets absorbed is destroyed quickly. Here is what the data show for acne, what the newer hair loss trials found, and where the evidence still runs thin for men on testosterone.
What Is Clascoterone and How Does It Block DHT in the Skin?
Clascoterone (cortexolone 17α-propionate) is a steroid-shaped molecule that occupies the androgen receptor in sebaceous glands and hair follicles so DHT cannot bind there. It shares the same four-ring backbone as DHT and spironolactone, which is why it fits the receptor.
When DHT binds the androgen receptor in a sebocyte, the cell makes more oil and releases inflammatory signals such as IL-6 and IL-8. In the scalp, the same receptor in dermal papilla cells drives the follicle shrinkage of male pattern baldness. Clascoterone interrupts that signal at the receptor itself.
In lab work on human scalp dermal papilla cells, clascoterone blocked androgen-driven gene transcription about as well as finasteride and cut DHT-stimulated IL-6 production more than enzalutamide, a prostate cancer antiandrogen Rosette, 2019. That is cell culture data, and it explains the mechanism rather than proving a clinical result.
Why Doesn't Clascoterone Lower Libido the Way Oral Antiandrogens Do?
Clascoterone is broken down into cortexolone, an inactive metabolite, almost as soon as it enters the circulation. Pharmacologists call this a soft drug: potent where applied, short-lived everywhere else.
In a Phase 2a study of 42 adults and adolescents applying the cream twice daily for 14 days, peak blood levels of clascoterone at steady state averaged 4.4 ng/mL in adults, and cortexolone stayed below the 0.5 ng/mL detection limit Mazzetti, 2019. Five Phase 1 studies found that 1% or less of the applied dose showed up in urine Di Stefano, 2025.
The other half of the answer is what clascoterone does not do. It does not inhibit 5-alpha reductase, and it does not signal the pituitary. Your serum testosterone and DHT stay where your TRT protocol puts them. Finasteride, by contrast, lowers serum DHT across the whole body, and that systemic drop is what worries men about sexual side effects.
How Well Does Clascoterone Cream Work for Acne?
Clascoterone 1% cream roughly doubles to triples the odds of clear or almost-clear skin compared with vehicle after 12 weeks. The two identical Phase 3 trials randomized 1,440 patients aged 9 and older with moderate to severe facial acne, who applied about 1 gram to the whole face twice daily Hebert, 2020.
Table 1. Phase 3 acne results for clascoterone 1% cream (Hebert et al., JAMA Dermatology, 2020)
| Outcome at week 12 | Trial 25: clascoterone | Trial 25: vehicle | Trial 26: clascoterone | Trial 26: vehicle |
|---|---|---|---|---|
| Treatment success (IGA clear/almost clear + 2 grades) | 18.4% | 9.0% | 20.3% | 6.5% |
| Change in inflammatory lesions | -19.3 | -15.5 | -20.0 | -12.6 |
| Change in non-inflammatory lesions | -19.4 | -13.0 | -19.4 | -10.8 |
Those 12-week numbers undersell the drug. In the long-term extension, facial treatment success rose to 30.2% at 12 months, and truncal acne success reached 31.7% after 9 months of use Eichenfield, 2024. The truncal figure matters most to TRT users, because back and shoulder acne is the pattern we see most often in the forum.
Compared with newer topical retinoids, clascoterone performs about the same. A 2024 meta-analysis of six Phase 3 trials found no significant difference in lesion reduction or success rates between clascoterone, trifarotene, and tazarotene Shergill, 2024. The American Academy of Dermatology's 2024 acne guideline gives clascoterone a conditional recommendation, a notch below the strong recommendations for benzoyl peroxide and topical retinoids Reynolds, 2024.
One caution when reading these trials: about 62% of participants were female and the median age was 18. Men in their 40s with testosterone-driven truncal acne were a small slice of the data.
Can Men on TRT Use Clascoterone for Testosterone-Related Acne?
Yes, and it is the only topical option that targets the androgen driver behind TRT acne without touching your hormone levels. No study has enrolled men on testosterone therapy specifically, so this is a mechanism-based choice rather than a trial-proven one.
The logic holds up. TRT acne is androgen-receptor acne: more testosterone means more DHT reaching the sebaceous gland. Retinoids and benzoyl peroxide work downstream on clogged pores and bacteria. Clascoterone works upstream on the hormone signal, so it pairs well with them. The AAD guideline recommends combining topical agents with different mechanisms Reynolds, 2024.
These practical points come up repeatedly in ExcelMale discussions of TRT acne:
- Surface area drives cost. One gram twice daily covers the face, so a 60 g tube lasts about a month. Covering the back and chest takes several times that amount.
- Fix the protocol first. Large weekly or biweekly injections create testosterone peaks that often trigger breakouts. Splitting the same weekly dose into two or more smaller injections flattens those peaks, and many men clear up without adding anything.
- Severe or scarring acne still calls for isotretinoin, which the AAD rates as a strong recommendation for that situation. Clascoterone is a tool for mild to moderate disease.
What Did the Phase 3 Trials Show for Clascoterone and Male Pattern Hair Loss?
The 5% clascoterone solution grew significantly more hair than placebo in two Phase 3 trials, with relative improvements in target-area hair count of 539% in SCALP 1 and 168% in SCALP 2. Cosmo Pharmaceuticals announced those topline results in December 2025 Cosmo, December 2025.
SCALP 1 and SCALP 2 enrolled 1,465 men with mild to moderate androgenetic alopecia at 51 sites in the US and Europe. Men were randomized 2:1 to twice-daily clascoterone 5% solution or vehicle for 6 months, followed by a 6-month extension HCPLive, 2025. Dr. Maria Hordinsky, an investigator, reported no significant sexual side effects linked to the solution.
In April 2026, Cosmo released 12-month data. Men who stayed on clascoterone had 2.39 times the target-area hair count improvement of men switched to placebo at month 6, and hair in the switched group declined after stopping Cosmo, April 2026. A US new drug application is planned for early 2027.
Why Should You Read the 539% Figure Carefully?
A relative improvement of 539% tells you how clascoterone compared with a small placebo response, and it says nothing about how many hairs actually grew. Cosmo has not yet released absolute hair counts per square centimeter, which is the number that lets you compare clascoterone with finasteride or minoxidil. The two trials also differed by more than threefold on the same endpoint. Until the full data appear in a peer-reviewed journal, treat these figures as promising and incomplete.
Is the Scalp Solution as Systemically Clean as the Acne Cream?
Not quite. A Phase 1 cardiac safety study noted that, unlike the cream, the solution formulation developed for hair loss produces measurable systemic concentrations and some accumulation of clascoterone Täubel, 2021. At a supratherapeutic 7.5% dose, it had no effect on the QT interval. Measurable blood levels do not mean anti-androgenic effects, and the Phase 3 safety data look similar to vehicle. It does mean the safety record of the 1% acne cream cannot be copied over to the scalp product automatically.
How Does Clascoterone Compare With Finasteride, Minoxidil, and Spironolactone?
Clascoterone is the only option in this group that blocks androgens locally without changing blood hormone levels. The table puts the main choices side by side for a man on TRT.
Table 2. Androgen-related acne and hair loss options for men
| Treatment | How it works | Lowers serum DHT? | Blocks androgens system-wide? | Status for men |
|---|---|---|---|---|
| Clascoterone 1% cream (Winlevi) | Topical androgen receptor blocker | No | No | FDA-approved for acne (age 12+) |
| Clascoterone 5% solution (Breezula) | Topical androgen receptor blocker | No | No meaningful effect reported | Investigational; US filing planned early 2027 |
| Oral finasteride 1 mg | 5-alpha reductase type 2 inhibitor | Yes | Yes, via lower DHT | FDA-approved for hair loss |
| Minoxidil (topical or oral) | Prolongs hair growth phase; not hormonal | No | No | Topical FDA-approved; oral used off-label |
| Oral spironolactone | Systemic androgen receptor blocker | No | Yes | Rarely used in men due to gynecomastia and libido loss |
For hair loss, clascoterone is not a replacement for finasteride yet. Finasteride has decades of data and is available today. What clascoterone may offer, once approved, is a DHT-pathway treatment for men who stopped finasteride because of sexual side effects or refuse to try it. Minoxidil works through a different pathway, so the two would be natural partners, though no published trial has tested that combination. Our hair loss review thread covers the current options in more depth.
What Side Effects Should You Expect From Clascoterone?
Most men will notice nothing beyond mild redness or dryness where they apply it. In the long-term extension study, the most common local reactions on the face were scaling or dryness (10.0%) and redness (8.0%), and most were trace or mild Eichenfield, 2023.
The one systemic signal is adrenal. Clascoterone is related to cortisol precursors, and under maximum-use conditions it can briefly suppress the hypothalamic-pituitary-adrenal (HPA) axis. In two Phase 2 studies, 5 of 69 patients applying large amounts for 14 days had an abnormal cortisol stimulation test. All five were normal again about 4 weeks later, and none had clinical signs of adrenal insufficiency Bhatia, 2024.
This is where TRT users should think ahead. The maximum-use studies involved exactly what a man with back acne might do: covering large areas of skin twice a day. The prescribing information for Winlevi also reports potassium elevations in 5% of treated patients versus 4% on vehicle. If you plan to apply clascoterone to your face, chest, and back, tell your prescriber so they can decide whether a cortisol or potassium check makes sense.
How Can You Get Clascoterone and What Does It Cost?
Clascoterone 1% cream requires a prescription and is sold in the US as Winlevi by Sun Pharma. It has since been approved in Europe as well. Without insurance coverage, the US cash price has run to several hundred dollars per 60 g tube, so check your plan or a manufacturer savings program before filling it.
Breezula, the 5% scalp solution, is not approved anywhere as of September 2026. Some compounding pharmacies and telehealth companies sell clascoterone scalp solutions made from the raw ingredient. Those products are not the formulation tested in SCALP 1 and SCALP 2, their vehicle and concentration vary, and no clinical data support them. If you go that route, know that you are running your own experiment.
Frequently Asked Questions
Does clascoterone lower testosterone?
No. Clascoterone blocks the androgen receptor in the skin where it is applied and does not affect testosterone production or conversion to DHT. Your serum testosterone and DHT stay the same.
Can clascoterone cause erectile dysfunction or low libido?
No sexual side effect signal has appeared in the acne or hair loss trials. The drug is broken down into inactive cortexolone once absorbed, which is why it avoids the systemic antiandrogen effects seen with oral drugs.
Is Breezula (clascoterone 5%) available for hair loss?
Not yet. Breezula met its Phase 3 endpoints in December 2025, and Cosmo plans to file for US approval in early 2027.
How long does clascoterone take to work for acne?
Expect to wait 12 weeks for a fair judgment. Success rates in trials kept rising through 12 months of continuous use.
Can I use clascoterone with tretinoin or benzoyl peroxide?
Yes. Combining clascoterone with a retinoid or benzoyl peroxide targets different parts of acne formation, and the AAD recommends multi-mechanism topical therapy.
Related ExcelMale Forum Discussions
- Why Does TRT Cause Acne, and How Do You Get Rid of It Without Quitting Testosterone?: protocol changes and topical options for acne that starts after beginning TRT.
- Clascoterone: New Hair Loss Treatment Safer than Finasteride?: a closer look at the 5% scalp solution and how it compares with finasteride.
- Clascoterone Cream 1%: Topical Androgen Receptor Inhibitor for Acne: the original forum discussion of Winlevi's FDA approval and trial data.
- Androgens and Acne: Perspectives on Clascoterone: a review of how androgens drive acne and where clascoterone fits.
- Managing Hair Loss: Comprehensive Review: finasteride, dutasteride, minoxidil, and other hair loss treatments for men.
Key References
1. Hebert A, Thiboutot D, Stein Gold L, et al. Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA Dermatology. 2020;156(6):621-630. doi:10.1001/jamadermatol.2020.0465
2. Eichenfield LF, Stein Gold L, Han J, et al. Integrated Short-Term and Long-Term Efficacy of Topical Clascoterone Cream 1% in Patients Aged 12 Years or Older With Acne Vulgaris. Journal of Drugs in Dermatology. 2024;23(1):1278-1283. doi:10.36849/JDD.7719
3. Eichenfield LF, Hebert AA, Stein Gold L, et al. Long-Term Safety and Efficacy of Twice-Daily Topical Clascoterone Cream 1% in Patients ≥12 Years of Age With Acne Vulgaris. Journal of Drugs in Dermatology. 2023;22(8):810-816. doi:10.36849/JDD.7592
4. Bhatia N, Eichenfield LF, Mazzetti A, et al. Hypothalamic-Pituitary-Adrenal Axis Response in Patients With Acne Vulgaris Treated With Clascoterone. Journal of Drugs in Dermatology. 2024;23(6):433-437. doi:10.36849/JDD.7997
5. Di Stefano AFD, Radicioni MM, Garhöfer G, et al. Pharmacokinetics, Safety, and Skin Irritation and Sensitization Potential of Clascoterone Cream in Early-Phase Clinical Study Participants. Clinical Pharmacology in Drug Development. 2025;14(10):742-753. doi:10.1002/cpdd.1561
6. Täubel J, Mazzetti A, Ferber G, et al. A Phase 1 Study to Investigate the Effects of Cortexolone 17α-Propionate, Also Known as Clascoterone, on the QT Interval. Clinical Pharmacology in Drug Development. 2021;10(6):572-581. doi:10.1002/cpdd.935
7. Mazzetti A, Moro L, Gerloni M, Cartwright M. Pharmacokinetic Profile, Safety, and Tolerability of Clascoterone Topical Cream, 1% in Subjects With Acne Vulgaris: An Open-Label Phase 2a Study. Journal of Drugs in Dermatology. 2019;18(6):563-568. PubMed 31251549
8. Rosette C, Rosette N, Mazzetti A, Moro L, Gerloni M. Cortexolone 17α-Propionate (Clascoterone) Is an Androgen Receptor Antagonist in Dermal Papilla Cells In Vitro. Journal of Drugs in Dermatology. 2019;18(2):197-201. PubMed 30811143
9. Shergill M, Ali MU, Abu-Hilal M. Comparison of the Efficacy of Clascoterone, Trifarotene, and Tazarotene for the Treatment of Acne: A Systematic Literature Review and Meta-Analysis. Dermatology and Therapy. 2024;14(5):1093-1102. doi:10.1007/s13555-024-01175-3
10. Reynolds RV, Yeung H, Cheng CE, et al. Guidelines of Care for the Management of Acne Vulgaris. Journal of the American Academy of Dermatology. 2024;90(5):1006.e1-1006.e30. doi:10.1016/j.jaad.2023.12.017
Trial announcements (not yet peer reviewed): Cosmo Pharmaceuticals, SCALP 1 and SCALP 2 topline results, December 2025; Cosmo Pharmaceuticals, Phase III 12-month data, April 2026; HCPLive interview with Maria Hordinsky, MD, December 2025.
Conclusion
Here is something the trial summaries skip. Clascoterone gives TRT users a clean way to test what is actually driving their skin. Men often blame acne on estradiol and start an aromatase inhibitor, which drops estradiol and rarely fixes the breakouts. If a receptor blocker applied to the skin clears the acne while your testosterone stays at 900 ng/dL, you have your answer: the problem was androgen signaling at the gland, and your estradiol can stay where it is.
If you are dealing with breakouts right now, start with the protocol adjustments in our TRT acne guide. If hair is your bigger worry, follow the clascoterone 5% hair loss thread for updates as the FDA filing moves forward.
By Nelson Vergel | B.S. Chemical Engineering, MBA | Founder, ExcelMale.com | 34+ years on TRT | NIH and FDA advisory panel service | Author: Testosterone: A Man's Guide, Beyond Testosterone, The hCG Advantage, and From Pills to Implants. Updated September 2026.
About ExcelMale: ExcelMale.com is a men's health community founded by Nelson Vergel, with more than 24,000 members and over 20 years of archives covering testosterone replacement, hormone optimization, fertility, and men's sexual health.
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