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Corticosteroid

Clascoterone for Male Pattern Baldness (SCALP2 Trial)

Phase 3
Recruiting
Research Sponsored by Cassiopea SpA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject who has mild to moderate AGA in temple and vertex region, rating III vertex to V on the Modified Norwood-Hamilton Scale, with a history of ongoing hair loss
Subject who is male ≥18 years old
Must not have
Subject who had scalp hair transplants at any time
Subject who has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the IMP or examination method
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Pivotal Trial

Summary

This trial aims to determine if Clascoterone can help men with male pattern hair loss. The study will compare Clascoterone solution to a placebo in two parts. In Part 1

Who is the study for?
This trial is for men over 18 with mild to moderate male pattern baldness at the top and temple areas of the head. Participants must be willing to keep their hair style, length, color consistent, follow study instructions at home, maintain their diet and supplement patterns, and use contraception if necessary.
What is being tested?
The SCALP2 study tests Clascoterone solution's effectiveness in treating male pattern hair loss compared to a placebo. It has two parts: an initial double-blind phase where neither doctors nor participants know who gets real treatment or placebo; followed by a single-blind phase for responders only.
What are the potential side effects?
Potential side effects are not explicitly listed but may include scalp irritation as subjects' scalps will be checked for this during visits. Other risks could relate to typical topical treatments such as skin reactions or systemic absorption effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have ongoing hair loss rated III-V on a specific scale.
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I am a man and I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a hair transplant on my scalp.
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I do not have skin conditions on my scalp that could affect treatment application.
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I have never participated in a study involving Clascoterone.
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I do not have any skin conditions that could affect the study treatment evaluation.
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I can communicate and cooperate with my doctor without issues.
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I have experienced hair loss due to reasons other than male/female pattern baldness.
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I have used specific treatments on my scalp.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in non-vellus Total Area Hair Count (TAHC)
Subject's assessment of own hair coverage
Secondary study objectives
Changes in non-vellus TAHC
Changes in subject's assessment of satisfaction score

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Vehicle Part 1 + Clascoterone Part 2Experimental Treatment2 Interventions
Subjects treated for the first 6 months Part 1 in double-blind with Vehicle followed by 6 months Part 2 in the single-blind label with Clascoterone 5% solution.
Group II: Clascoterone Part 1 and Part 2Experimental Treatment1 Intervention
Subjects treated for 12 months with Clascoterone 5% solution (both in double-blind Part 1 and in the single-blind Part 2 of the study).
Group III: Clascoterone Part 1 + Vehicle Part 2Experimental Treatment2 Interventions
Subjects treated for the first 6 months Part 1 in double-blind with Clascoterone 5% solution followed by 6 months Part 2 in the single-blind label with Vehicle.
Group IV: Vehicle Part 1 and Part 2Placebo Group1 Intervention
Subjects treated for 12 months with Vehicle (both in double-blind Part 1 and in the single-blind Part 2 of the study).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vehicle solution
2009
Completed Phase 3
~370

Find a Location

Who is running the clinical trial?

Cassiopea SpALead Sponsor
6 Previous Clinical Trials
2,834 Total Patients Enrolled
Ergomed PLCNETWORK
1 Previous Clinical Trials
726 Total Patients Enrolled
Pharmapace IncUNKNOWN
1 Previous Clinical Trials
726 Total Patients Enrolled
Canfield Scientific Inc.UNKNOWN
2 Previous Clinical Trials
816 Total Patients Enrolled
ICON Clinical ResearchIndustry Sponsor
51 Previous Clinical Trials
14,761 Total Patients Enrolled
Alessandro Mazzetti, M.D.Study DirectorCassiopea SpA
1 Previous Clinical Trials
726 Total Patients Enrolled
~311 spots leftby Dec 2025