Clascoterone for Male Pattern Baldness

(SCALP1 Trial)

Recruiting at 23 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Cassiopea SpA

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

Disqualifiers: Scalp disorders, Hair transplants, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 and how well the drug is tolerated by subjects. Within this study, the Clascoterone solution will be compared to a placebo. The study has 2 parts: Part 1 will see if Clascoterone solution is effective and safe compared to a placebo when applied twice daily for up to 6 months. Part 2 will see the long-term safety and efficacy of the Clascoterone solution compared to placebo for additional 6 months in subjects defined as ''responders'' in Part 1. A responder is defined as someone who have responded to the study drug, based on research data. Part 1 of the study is double-blind, meaning that neither the subject nor the study doctor knows which treatment subject is receiving. Part 2 of the study is single-blind and only the study doctor doing the study knows which treatment subject is receiving. Part 1 of the study will start with baseline visit during which subjects will be randomly assigned (by chance) in ratio 2:1 to apply either Clascoterone or placebo solution to their balding areas of the scalp. Subjects will have 5 clinic visits and 2 follow-up phone calls during 6 months of Part 1 duration. Subjects identified as Part 1 responders at Month 6 visit will be again randomly assigned in ratio 2:1 to receive either study drug or placebo. Part 2 of the study will consist of 2 additional clinic visits and treatment will last for further 6 months. Each subject will have also an end of study visit one month after the study drug treatment has been completed or discontinued (it will be one month after end of Part 1 for not responder subjects). For those subjects who complete the whole study (Part 1 and Part 2), the total duration of the study will be about 14 months, with 12 months of treatment with a total of eight clinic visits and two phone calls. Subjects taking part in this study will have the medical tests or procedures described below. * They will be asked about their previous medical history and current medications. * A brief physical examination will be performed. * Vital signs, weight and height will be measured. * Electrocardiograms will be performed. * Subject's scalp will be checked for any signs of irritation. * Two different types of photos will be taken during this study: "global photos", i.e. general photos of the subject's scalp and "macro photos", i.e. close up photos of a region of the subject's scalp. Global photos will be taken to help the subject and the study doctor to assess whether there has been a change in subject's hair growth. Macro photos will be used to count the number of hairs in a region of the subject's scalp and measure other properties of the hair (hair width and hair darkness). * Blood draws and urine sample collection for safety laboratory tests. * Subject will be asked to complete, on site, the following two questionnaires: * Cosmetic Evaluation - a couple of cosmetic questions on acceptability and how easy the study drug is to use. * Male Androgenetic Alopecia Questionnaire - some questions about subject's hair assessment. Eligible subjects will be given a supply of the study drug and shown how to use and store it. The first study drug dose will be applied at the clinic under the supervision of the study staff. Subjects will be instructed to apply about 1.5 ml of study drug with a dropper to the balding areas of the scalp on the vertex and the temples twice daily, once in the morning and once in the evening. Subjects will be asked to bring back all used containers of study drug and all unused study drug to each study visit. Subjects will also be given a diary, shown what things have to be recorded on it and asked to bring back the completed diary to the study center at each visit.

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.

What data supports the effectiveness of the drug Clascoterone for male pattern baldness?

Clascoterone is an antiandrogen drug that has shown effectiveness in treating acne by blocking androgen receptors, which are also involved in male pattern baldness. Studies suggest it may inhibit the action of dihydrotestosterone (DHT), a hormone linked to hair loss, making it a promising candidate for treating male pattern baldness. ^{1 2 3 4 5}

Is clascoterone safe for use in humans?

Clascoterone, used as a topical cream for acne, is generally safe for people over 12 years old, with most side effects being mild, like skin irritation. Some adolescents experienced temporary hormonal changes that resolved after stopping the treatment. ^{1 3 4 5 6}

How does the drug Clascoterone differ from other treatments for male pattern baldness?

Clascoterone is unique because it is a topical antiandrogen that works by blocking androgen receptors in hair follicles, potentially reducing the effects of dihydrotestosterone (DHT), a hormone linked to male pattern baldness. Unlike oral treatments, it is applied directly to the scalp, which may minimize systemic side effects. ^{1 2 3 5 7}

Research Team

Alessandro Mazzetti, M.D.

Principal Investigator

Cassiopea SpA

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Clascoterone (Anti-androgen)

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Clascoterone: First Approval. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Cortexolone 17α-Propionate (Clascoterone) is an Androgen Receptor Antagonist in Dermal Papilla Cells In Vitro [2019]

3. Spain pubmed.ncbi.nlm.nih.gov

Clascoterone for treatment of acne. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of 1% Clascoterone Cream in Patients Aged > 12 Years With Acne Vulgaris. [2023]

5. United States 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 [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 Years. [2022]

7. England pubmed.ncbi.nlm.nih.gov

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