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Anti-androgen

Clascoterone Part 1 + Vehicle Part 2 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

SCALP1 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.Check my eligibility
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.See study design
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.

SCALP1 Trial Eligibility Criteria

Inclusion Criteria

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

SCALP1 Trial 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

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

SCALP1 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?

Ergomed PLCNETWORK
1 Previous Clinical Trials
726 Total Patients Enrolled
ICON Clinical ResearchIndustry Sponsor
49 Previous Clinical Trials
14,490 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.

Are patients currently eligible to participate in this ongoing clinical trial?

"The clinical trial, currently searching for suitable candidates, was initially posted on June 21st, 2023 and last revised on February 9th, 2024 according to information available on clinicaltrials.gov."

Answered by AI

How large is the overall participant pool in this medical study?

"A minimum of 726 eligible participants must be recruited to facilitate the study. The trial, overseen by Cassiopea SpA, will take place at multiple sites such as Tbilisi Cancer Center in Tbilisi, California and Aversi Clinic in San Diego, Florida."

Answered by AI

At how many distinct sites is the management of this study taking place?

"There are 24 active sites participating in this medical trial, including establishments like Tbilisi Cancer Center in Tbilisi, Aversi Clinic in San Diego, and Therapeutics Clinical Research in Miami. Additionally, there are two dozen other locations involved."

Answered by AI

What is the safety profile of combining Clascoterone Part 1 with Vehicle Part 2 for individuals undergoing treatment?

"Team Power assesses the safety of Clascoterone Part 1 + Vehicle Part 2 as a Level 3 on our scale. This rating is based on the trial being in Phase 3, where some efficacy data exists alongside extensive safety data."

Answered by AI

Who else is applying?

What site did they apply to?
Hassman Research Institute
DermResearch
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Interested in hair regrowth. I’ve tried several combinations of things that had limiting success. I guess I’d like to try a few more things..
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss
2023. "A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05910450.
All > Androgenetic Alopecia > Alopecia Areata
~66 spots leftby Jun 2024
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