Clascoterone trial results now include two completed Phase 3 studies called SCALP 1 and SCALP 2. Together, the registry records list 1,465 men. The sponsor reported top-line findings in December 2025, but the full results have not been published in a peer-reviewed paper and no regulatory decision has been announced.
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.
| Evidence stage | 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 research sit?
2-deoxy-D-ribose (2DDR) is a cosmetic ingredient with preclinical and animal research only for hair-related outcomes. The often-cited 2024 University of Sheffield and COMSATS University paper used a mouse model. That evidence stage cannot establish results in people.
An independent study record, NCT07502976, lists a 2DDR hydrogel trial that began recruiting in January 2026. The registry estimates 60 participants and lists October 2026 for primary completion. No results are posted, and the study is not about a commercial product.
Deoxylocks is a physician-formulated cosmetic scalp hydrogel with 5% 2DDR. Nothing in the SCALP trials was conducted on this cosmetic product, and this article does not rank products or expected results.
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.
Did SCALP 1 and SCALP 2 include women?
No. The registry records list male participants, so the reported findings do not answer the same questions for women.
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 17 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)
- 2-Deoxy-D-ribose hydrogel vs minoxidil 5% (NCT07502976)
- Stimulation of hair regrowth in an animal model of androgenic alopecia using 2-deoxy-D-ribose
- University of Sheffield announcement
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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.
