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Corticosteroid

Clascoterone Part 1 and Part 2 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

SCALP2 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.Check my eligibility

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.See study design

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.

SCALP2 Trial 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.

SCALP2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in non-vellus Total Area Hair Count (TAHC)

Subject's assessment of own hair coverage

Secondary outcome measures

Changes in non-vellus TAHC

Changes in subject's assessment of satisfaction score

SCALP2 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 / 2Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different geographical areas can patients access this clinical trial?

"This research project is being carried out at Investigate MD in Scottsdale, Arizona, Revival Research Institute in Troy, Michigan, and the Department of Dermatology and Allergy at Johannes Gutenberg-Universität KöR in Mainz, Florida. Furthermore, there are an additional 27 sites participating across various other locations."

Answered by AI

What is the total number of participants being selected for enrollment in this clinical trial?

"Indeed, the details on clinicaltrials.gov highlight that this trial is actively seeking participants. The trial was initially uploaded on August 17th, 2023, and last revised on February 9th, 2024. A total of 726 individuals are sought after across 27 diverse locations for enrollment in the study."

Answered by AI

Are potential participants still able to apply for enrollment in this ongoing research study?

"Indeed, the information available on clinicaltrials.gov indicates that recruitment is ongoing for this particular trial. The trial was first posted on August 17th, 2023, and its most recent update was made on February 9th, 2024. A total of 726 participants are sought across a network of 27 sites."

Answered by AI

Has the FDA granted approval for both Part 1 and Part 2 of Clascoterone?

"Scoring a 3 on the safety assessment scale, Clascoterone Part 1 and Part 2 are deemed secure by our team at Power due to being in Phase 3. This indicates some evidence of effectiveness along with multiple rounds of data verifying its safety profile."

Answered by AI