Clascoterone is a topical androgen receptor inhibitor that has completed two Phase 3 trials in male pattern hair loss. The programme ran under the name SCALP 1 and SCALP 2, enrolled 1,465 men between them, and reported in December 2025. It is not FDA-approved for hair loss. If it were approved it would be the first topical androgen receptor inhibitor for the condition.
The short version
- Clascoterone 5% solution is applied to the scalp and acts on the androgen receptor locally rather than lowering hormones throughout the body.
- Phase 2 tested four dose regimens against vehicle over 12 months.
- Phase 3 ran as two trials: SCALP 1 (NCT05910450, 703 enrolled) and SCALP 2 (NCT05914805, 762 enrolled), both listed as completed.
- The sponsor of record on both registry entries is Cassiopea SpA, a Cosmo Pharmaceuticals company.
- Both Phase 3 trials enrolled men only.
How did the clascoterone trials progress?
The compound has been in hair studies for roughly a decade, first under the development code CB-03-01. The table below is the trial lineage, not a ranking.
| Study | Enrolled | Arms | Design |
|---|---|---|---|
| Phase 2 (NCT02279823) | 95 | CB-03-01 solution vs comparator | Earlier dose-finding work |
| Phase 2 dose-ranging | ~400 reported | 2.5%, 5%, 7.5% twice daily; 7.5% once daily; vehicle | 12 months; terminal hair count and patient assessment |
| Phase 3 SCALP 1 (NCT05910450) | 703 | 5% solution vs vehicle | 6-month double-blind plus 6-month extension |
| Phase 3 SCALP 2 (NCT05914805) | 762 | 5% solution vs vehicle | 6-month double-blind plus 6-month extension |
What did Phase 2 measure?
The dose-ranging study compared 2.5%, 5% and 7.5% solutions against a vehicle control over 12 months, with terminal hair count in a target area and a patient self-assessment as the endpoints. Reported average gains over placebo were 10.2 hairs for 2.5% twice daily, 13.8 for 5% twice daily, 14.3 for 7.5% twice daily and 12.7 for 7.5% once daily. The sponsor reported adverse events and local skin reactions similar to vehicle, and no systemic effect on cortisol.
Note what that pattern shows: the jump from 2.5% to 5% was larger than the jump from 5% to 7.5%. Dose-response curves that flatten are a common reason a programme carries the middle dose rather than the highest one into Phase 3.
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What did the Phase 3 trials report?
The two Phase 3 trials used target area hair count and a patient-reported measure of perceived improvement as co-primary endpoints, across a six-month double-blind period followed by a six-month single-blind extension. Cosmo Pharmaceuticals reported a 5.39-fold relative improvement in target area hair count versus vehicle in SCALP 1 and a 1.68-fold relative improvement in SCALP 2.
That gap between the two trials is worth sitting with. Two trials of the same compound, same dose and same design produced relative improvements differing by more than threefold. Relative measures are sensitive to how the comparator arm performs, so a vehicle group that does slightly better shrinks the ratio without the active arm changing at all. It is one reason regulators look at absolute counts alongside ratios.
The company has said a 12-month safety follow-up was due to complete in spring 2026, ahead of parallel FDA and EMA submissions.
What these results do not tell you
- Relative is not absolute. A 5.39-fold relative improvement describes a ratio between two arms. It does not say how many hairs an individual gained.
- The two trials disagreed in magnitude. SCALP 1 and SCALP 2 reported 5.39-fold and 1.68-fold. Quoting only the larger number misrepresents the programme.
- Men only. Both Phase 3 trials enrolled men. Nothing here transfers automatically to female pattern hair loss.
- Completed is not approved. Both trials read as completed on the registry. That is not the same as a regulatory decision, and submission timelines move.
- Full results are not peer-reviewed here. The figures above come from sponsor announcements and trade coverage, not a published paper.
Where does 2-deoxy-D-ribose sit against this?
Further back, and in a different regulatory category. 2-deoxy-D-ribose (2DDR) is a naturally occurring pentose sugar. The work most often cited is a 2024 paper in Frontiers in Pharmacology from the University of Sheffield and COMSATS University, which applied it in a testosterone-driven mouse model and reported hair growth outcomes in that model similar to the minoxidil comparator used in the same study. That is an animal study, and the lead author described the work publicly as early stage.
One independent randomised controlled trial of a 2-deoxy-D-ribose hydrogel (NCT07502976) began recruiting in January 2026 at Kasr El Aini Hospital, with 60 participants estimated and primary completion listed for October 2026. No results have been posted. That trial is run by an academic hospital and is not a study of any commercial product.
So the honest summary is: an animal model, a mechanistic hypothesis about blood vessel formation, and one human trial that has not reported. Set against a completed Phase 3 programme, that is not a close comparison, and this article does not make one.
Deoxylocks is a physician-formulated cosmetic hydrogel containing 5% 2-deoxy-D-ribose. It is a scalp care product sold for cosmetic use. It is not a drug, it has not been through the trials described in this article, and nothing here was conducted on it. Anyone weighing the options in this article should speak with a clinician about their own situation.
Common questions
Is clascoterone available for hair loss now?
No. It is investigational for androgenetic alopecia and not FDA-approved for that use. A clascoterone cream is approved for acne, which is a different product and indication.
How is it different from finasteride?
Both act on androgen signalling, but clascoterone is applied topically and is designed to act at the receptor in the scalp rather than altering hormone levels systemically. They have not been compared head-to-head in the trials described here.
Why did the two Phase 3 trials report such different numbers?
The published figures are relative improvements versus vehicle, which depend on how the vehicle arm performed. Differences of this size between otherwise identical trials are not unusual and are one reason two trials are required.
Where can I read the trial records?
SCALP 1 is NCT05910450 and SCALP 2 is NCT05914805. Both are linked below.
Last checked 15 August 2026.
Sources
Primary sources for the figures in this article. Registry records were checked on 15 August 2026.
- SCALP 1 (NCT05910450)
- SCALP 2 (NCT05914805)
- Clascoterone Phase 2 (NCT02279823)
- Dermatology Times coverage of the clascoterone Phase 3 readout
- Stimulation of hair regrowth in an animal model of androgenic alopecia using 2-deoxy-D-ribose
- University of Sheffield announcement
- 2-Deoxy-D-ribose hydrogel vs minoxidil 5% (NCT07502976)
Deoxylocks 5% 2DDR Scalp Hydrogel
A physician-formulated cosmetic hydrogel for nightly scalp care. Non-hormonal, clear and odorless, applied once daily to the scalp. Backed by a 90-day risk-free return policy.
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
