Clascoterone for Male Pattern Baldness

(SCALP1 Trial)

Recruiting at 23 trial locations

Overseen By Janet DuBois, MD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Cassiopea SpA

Must not be taking: Beta blockers, Corticosteroids, Retinoids, others

Disqualifiers: Scalp disorders, Hair transplants, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

726 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Clascoterone, a topical medication, can help men with male pattern baldness regrow hair and if it is safe and well-tolerated. The study will compare Clascoterone to a placebo (a substance with no active medication) to assess its effectiveness. Participants with mild to moderate male pattern hair loss, particularly in the temple and top of the head areas, and who have experienced ongoing hair loss, might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment for male pattern baldness.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications and treatments that could affect hair growth before starting the study. This includes some topical and systemic medications like minoxidil, corticosteroids, and certain vitamins. If you're taking any of these, you may need to stop them for a specific period before joining the trial.

Is there any evidence suggesting that Clascoterone is likely to be safe for humans?

Research has shown that Clascoterone has been tested for safety in treating male pattern hair loss. In earlier studies, participants found Clascoterone easier to tolerate than some other treatments, such as cyproterone acetate, suggesting it might be gentler on the scalp.

These studies also reported no serious side effects from using Clascoterone. Most users did not experience major problems. Some minor issues, like scalp irritation, could occur but are uncommon.

Overall, the evidence so far suggests that Clascoterone is generally safe for treating hair loss. However, since this study is in a later phase, more participants will help researchers better understand its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for male pattern baldness?

Clascoterone is unique because it targets male pattern baldness by blocking dihydrotestosterone (DHT) directly at the hair follicle. Unlike standard treatments like finasteride, which reduce DHT levels systemically and can lead to side effects like reduced libido, clascoterone acts locally, potentially minimizing these risks. Researchers are excited about clascoterone because it offers a novel approach with the possibility of fewer side effects and more targeted action, which could revolutionize the way male pattern baldness is treated.

What evidence suggests that Clascoterone might be an effective treatment for male pattern baldness?

Research shows that Clascoterone can help with male pattern baldness by blocking the hormone DHT, which causes hair follicles to shrink. In this trial, participants may receive Clascoterone for different durations: some for 12 months and others for 6 months followed by a vehicle treatment. Studies have found that Clascoterone can improve hair growth within a year of starting treatment. It also continues to enhance hair thickness and increase the number of hairs for up to 10 years. Applied directly to the scalp, this treatment offers a promising option for those experiencing hair loss. ^{1 2 3 6 7}

Who Is on the Research Team?

Alessandro Mazzetti, M.D.

Principal Investigator

Cassiopea SpA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I agree to not change my hairstyle, length, or color during the study.

I am willing to follow the study's home instructions and can return for clinic visits.

I agree to use effective birth control if I am sexually active.

Exclusion Criteria

Subject who has used or is suspected to be using anabolic steroids

I have never participated in a study involving Clascoterone.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive Clascoterone or placebo solution applied twice daily for 6 months in a double-blind manner

6 months

5 clinic visits, 2 follow-up phone calls

Treatment Part 2

Long-term safety and efficacy of Clascoterone or placebo solution for additional 6 months in a single-blind manner for responders

6 months

2 clinic visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

1 end of study visit

What Are the Treatments Tested in This Trial?

Interventions

• Clascoterone

Trial Overview 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.

How Is the Trial Designed?

Group I: Vehicle Part 1 + Clascoterone Part 2 Experimental Treatment 2 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 2 Experimental Treatment 1 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 2 Experimental Treatment 2 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 2 Placebo Group 1 Intervention

Subjects treated for 12 months with Vehicle (both in double-blind Part 1 and in the single-blind Part 2 of the study)

Who Is Running the Clinical Trial?

Cassiopea SpA

Lead Sponsor

Trials

7

Recruited

3,600+

Ergomed PLC

Collaborator

Trials

2

Recruited

1,500+

ICON Clinical Research

Industry Sponsor

Trials

52

Recruited

15,100+

Pharmapace Inc

Collaborator

Trials

2

Recruited

1,500+

Canfield Scientific Inc.

Collaborator

Trials

3

Recruited

1,500+

Published Research Related to This Trial

Clascoterone cream, particularly at a concentration of 1% applied twice daily, showed the highest efficacy in reducing both inflammatory and non-inflammatory acne lesions in a study of 363 participants, with significant improvements observed at week 12.

The treatment was well tolerated, with most adverse events being mild and resolving by the end of the study, indicating a favorable safety profile for clascoterone cream in treating acne.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 2b, Randomized, Double-Blind Vehicle Controlled, Dose Escalation Study Evaluating Clascoterone 0.1%, 0.5%, and 1% Topical Cream in Subjects With Facial Acne Mazzetti, A., Moro, L., Gerloni, M., et al.[2020]

Clascoterone is a newly approved topical treatment for acne vulgaris, representing the first novel mechanism of action in 40 years, which may provide an effective alternative to existing treatments.

Clinical data from two Phase III randomized controlled trials suggest that clascoterone is both effective and safe, potentially offering similar efficacy to current medications while minimizing systemic side effects associated with other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 Years. Piszczatoski, CR., Powell, J.[2022]

Clascoterone is a novel topical antiandrogen approved for treating acne, offering a safe and effective alternative to oral antiandrogens, particularly for male patients and certain females who cannot use systemic treatments.

While generally well tolerated, clascoterone can cause localized skin irritation and, in some adolescents, biochemical evidence of HPA suppression, which resolved after stopping the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clascoterone for treatment of acne. Manjaly, C., Martinez, J., Barbieri, J., et al.[2023]

Clascoterone is the first topical androgen antagonist approved by the FDA for treating acne, effectively reducing both non-inflammatory and inflammatory acne lesions without systemic side effects.

In Phase III studies, clascoterone demonstrated significant safety and efficacy, making it a promising new option for acne management that targets the underlying hormonal causes of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Androgens and acne: perspectives on clascoterone, the first topical androgen receptor antagonist. Kircik, LH.[2021]

In a pooled analysis of two phase 3 studies involving 712 patients aged 12 years and older, 1% clascoterone cream significantly improved acne treatment outcomes compared to a vehicle, with 19.9% of patients achieving treatment success versus 7.7% for the vehicle group.

Clascoterone demonstrated a favorable safety profile, with low rates of local skin reactions that were similar to those observed in the vehicle group, indicating it is a safe option for treating moderate-to-severe facial acne vulgaris.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of 1% Clascoterone Cream in Patients Aged > 12 Years With Acne Vulgaris. Hebert, A., Eichenfield, L., Thiboutot, D., et al.[2023]

Clascoterone (Winlevi®) is a topical cream approved in the USA for treating acne vulgaris in patients aged 12 and older, acting as an androgen receptor inhibitor to potentially reduce acne-causing signals.

The drug works by competing with dihydrotestosterone for binding to androgen receptors in skin glands, although its exact mechanism for acne treatment is still not fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clascoterone: First Approval. Dhillon, S.[2022]

Cortexolone 17α-propionate (clascoterone) is a promising topical treatment for androgenetic alopecia (AGA), showing potent antiandrogen effects similar to finasteride, a common oral medication.

Clascoterone not only inhibits androgen receptor activity effectively but also significantly reduces IL-6 synthesis in scalp cells, suggesting it may be a superior option for targeting the underlying mechanisms of AGA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortexolone 17α-Propionate (Clascoterone) is an Androgen Receptor Antagonist in Dermal Papilla Cells In Vitro Rosette, C., Rosette, N., Mazzetti, A., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05914805

A Study to Evaluate the Efficacy and Safety of Clascoterone ... The purpose of the study is to see if Clascoterone can help people with male pattern hair loss to recovery and see if the treatment is effective and safe.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05910450?term=AREA%5BBasicSearch%5D(AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(Androgenetic%20Alopecia)))&rank=7

A Study to Evaluate the Efficacy and Safety of Clascoterone ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10173235/

Androgenetic Alopecia: Therapy Update - PMC The drug improves hair growth within 1 year of treatment, and further improvement up to 10 years of treatment [25]. It is more effective at ...

4. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-clascoterone-solution-for-treating-male-pattern-hair-loss/

Study on the Effectiveness and Safety of Clascoterone ... The purpose of the study is to evaluate how effective and safe the Clascoterone solution is in treating male pattern hair loss.

5. journals.viamedica.pl journals.viamedica.pl/forum_dermatologicum/article/download/101208/78608

Topical solutions for androgenetic alopecia Clascoterone, a newer topical anti-androgen, prevents DHT from binding to hair follicle receptors, showing promising results in im- proving hair ...

6. go.drugbank.com go.drugbank.com/drugs/DB12499/clinical_trials?conditions=DBCOND0064452&phase=3&purpose=treatment&status=recruiting

Clascoterone Recruiting Phase 3 Trials for Androgenetic ... A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss. Clascoterone (DB12499).

7. hims.com hims.com/blog/breezula-clascoterone

Breezula for Hair Loss: How It Works & Side Effects Can Breezula stop male pattern balding ... A study to evaluate the efficacy and safety of clascoterone solution in treatment of male pattern hair ...