A 6-Month Phase 3, Multicenter, Prospective, Randomized, Double-Blind, Vehicle-Controlled Study, to Evaluate the Efficacy and Safety of Topically Applied Clascoterone (Cortexolone 17α-Propionate) Solution for the Treatment of Androgenetic Alopecia in Males, Followed by a 6-Month Single-Blind Treatment with Clascoterone or Vehicle BID Solution (SCALP 2)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-504421-39-00

Acronym

CB-03-01/38

Enrollment

629

Registered

2023-10-30

Start date

2023-11-21

Completion date

2025-07-16

Last updated

2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic Alopecia

Brief summary

Co-Primary Efficacy Endpoints: Changes from Pivotal Part 1 Baseline in non-vellus TAHC at Month 6. / Subject’s assessment of own hair coverage at Month 6, defined as the proportion of MAA-PRO core measure item 2 responder at Month 6.

Detailed description

1) Changes from Pivotal Part 1 Baseline in non-vellus TAHC at Month 3. 2) Changes in MAA-PRO SI single treatment satisfaction item (item 15) score at Month 6.

Interventions

DRUGClascoterone Solution

DRUGVehicle solution

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Co-Primary Efficacy Endpoints: Changes from Pivotal Part 1 Baseline in non-vellus TAHC at Month 6. / Subject’s assessment of own hair coverage at Month 6, defined as the proportion of MAA-PRO core measure item 2 responder at Month 6.	—

Secondary

Measure	Time frame
1) Changes from Pivotal Part 1 Baseline in non-vellus TAHC at Month 3. 2) Changes in MAA-PRO SI single treatment satisfaction item (item 15) score at Month 6.	—

Countries

Germany, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026