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Anti-androgen

Clascoterone for Male Pattern Baldness (SCALP1 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 is male ≥18 years old

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

Must not have

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

Subject who has any skin pathology or condition that could interfere with the evaluation of the IMP or requires use of interfering topical, systemic, or surgical therapy

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?

Men over 18 with mild to moderate male pattern baldness at the top and temple areas of the scalp, who are willing to keep their hair style and color consistent, follow study instructions, maintain their diet and supplement patterns, use birth control if applicable, and make required clinic visits.

What is being tested?

The trial is testing Clascoterone 5% solution versus a placebo. It's divided into two parts: The first part (6 months) checks for effectiveness and safety in a double-blind setup. Responders then enter Part 2 for another six months in a single-blind test for long-term effects.

What are the potential side effects?

Potential side effects aren't specified here but typically include scalp irritation where the solution is applied. Since it's being tested for safety, monitoring will include physical exams, vital signs checks, ECGs, blood tests, urine samples to catch any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man and I am 18 years old or older.

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I have ongoing hair loss rated III-V on a specific baldness scale.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have skin conditions on my scalp that could affect treatment application.

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I do not have skin conditions that could affect the treatment's evaluation.

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I have had a hair transplant on my scalp.

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I have experienced hair loss due to reasons other than male/female pattern baldness.

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I can communicate and cooperate with my doctor without issues.

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I have used specific treatments on my scalp.

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I have never participated in a study involving Clascoterone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

0 / 9Eligibility criteria met