Clascoterone for Male Pattern Baldness

(SCALP2 Trial)

Recruiting at 26 trial locations

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Cassiopea SpA

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you must stop all current medications, but certain medications and treatments must be stopped before joining. You cannot use specific topical or systemic treatments that affect hair growth, like minoxidil or finasteride, within certain timeframes before the trial. Check with the study team for details on your specific medications.

What data supports the idea that Clascoterone for Male Pattern Baldness (also known as: Clascoterone) is an effective treatment?

The available research shows that Clascoterone is being studied for its effectiveness in treating male pattern baldness. It works by blocking certain hormones that contribute to hair loss. In studies, Clascoterone was found to be as effective as another treatment called finasteride, which is already used for hair loss. Additionally, Clascoterone was better at reducing certain harmful effects in hair cells compared to another similar treatment, enzalutamide. This suggests that Clascoterone could be a promising option for treating male pattern baldness. ^{1 2 3 4 5}

What safety data is available for Clascoterone?

Clascoterone, approved for acne treatment, has been evaluated in several studies. In phase 3 studies, it was well tolerated with no major safety issues. Most adverse events were mild and resolved by the study's end. Some adolescents experienced temporary HPA suppression, which resolved after stopping treatment. Overall, Clascoterone is considered safe for use in patients over 12 years old. ^{2 3 4 5 6}

Is the drug Clascoterone a promising treatment for male pattern baldness?

Yes, Clascoterone is a promising drug for male pattern baldness. It works by blocking the effects of hormones that contribute to hair loss, and studies show it is effective and well-tolerated as a topical treatment. ^{1 2 3 5 7}

Research Team

Alessandro Mazzetti, M.D.

Principal Investigator

Cassiopea SpA

Eligibility Criteria

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.

Inclusion Criteria

I have ongoing hair loss rated III-V on a specific scale.

Subject who has provided written informed consent

Subject who agrees to maintain same dietary and supplement pattern

Exclusion Criteria

I have had a hair transplant on my scalp.

Subject is currently enrolled in an investigational drug or device study

Subject who is institutionalized because of legal or regulatory order

Treatment Details

Interventions

• Clascoterone (Corticosteroid)

Trial Overview 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.

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+

Pharmapace Inc

Collaborator

Trials

2

Recruited

1,500+

Canfield Scientific Inc.

Collaborator

Trials

3

Recruited

1,500+

ICON Clinical Research

Industry Sponsor

Trials

52

Recruited

15,100+

Findings from Research

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 (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]

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

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

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

Clascoterone: First Approval. [2022]

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]