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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 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