Clascoterone for Male Pattern Baldness

(SCALP2 Trial)

Recruiting at 32 trial locations

Overseen By Cassiopea SpA

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Cassiopea SpA

Must not be taking: Anabolic steroids, Minoxidil, Finasteride, others

Disqualifiers: Scalp disorders, Hair transplants, Eating disorders, 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: 9

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 can help men with male pattern baldness regrow hair and assess its safety and ease of use. Participants will apply either the Clascoterone solution or a placebo (an inactive substance resembling the treatment) to their scalp twice daily for up to 12 months. Eligible men should have mild to moderate hair loss in specific scalp areas, such as the temples and the top of the head. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.

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.

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

Research shows that Clascoterone has been tested for safety in treating male pattern baldness. Previous studies have found it to be generally well-tolerated. Specifically, an earlier study found that Clascoterone did not cause severe side effects compared to other treatments. Most side effects, if they occurred, were mild and included skin irritation at the application site.

Clascoterone is now in a later stage of clinical testing, indicating some evidence of safety for humans. However, the final results of ongoing studies will provide more detailed information about its safety. Overall, Clascoterone appears to be a promising treatment with manageable side effects for those considering participation in a clinical trial. ^{1 2 3 4 5}

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

Researchers are excited about Clascoterone for treating male pattern baldness because it offers a novel approach compared to current options like minoxidil and finasteride. Unlike these treatments, which primarily focus on altering hair growth cycles or hormone levels, Clascoterone is a topical solution that acts as an androgen receptor inhibitor. This means it targets the hormone activity directly in the scalp, potentially reducing hair loss without the systemic side effects associated with oral medications. Additionally, being a topical treatment, Clascoterone may offer a more user-friendly application for those looking for non-invasive solutions.

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

Research has shown that Clascoterone can help people with male pattern baldness grow more hair. It works by preventing a hormone called DHT, which is linked to hair loss, from attaching to hair follicles, thus promoting better hair regrowth. In this trial, participants will join different treatment arms, including those receiving Clascoterone for varying durations and those receiving a vehicle solution. Previous studies found that people noticed more hair growth within a year of using Clascoterone, and the benefits continued for up to 10 years. These positive results suggest that Clascoterone could effectively treat male pattern 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?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment Part 1

Participants receive Clascoterone or placebo solution applied twice daily for up to 6 months

6 months

5 visits (in-person), 2 follow-up phone calls

Treatment Part 2

Long-term safety and efficacy of Clascoterone or placebo for additional 6 months in responders

6 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Clascoterone

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.

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+

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+

Published Research Related to This Trial

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]

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]

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 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 (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]

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. 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 ...

3. 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.

4. 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 ...

5. perfecthairhealth.com perfecthairhealth.com/cb-03-01-breezula-hair-growth-results/

CB-03-01 (Breezula): Results, Side Effects, & Sourcing ... While Phase II clinical trials suggest CB-03-01 might significantly improve hair growth in those with androgenic alopecia, further research is ...

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 ...