Clascoterone Cream for Acne

Overseen By Study Coordinator

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Stanford University

Must be taking: Masculinizing hormone therapy

Must not be taking: Topical steroids

Disqualifiers: Pregnancy, Breast-feeding, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

18 Participants Needed

Trial Summary

What is the purpose of this trial?

Mechanism-based acne treatment for transgender patients receiving testosterone currently does not exist and is an unmet medical need. This study explores clascoterone to treat testosterone induced acne. Many treatments we use to treat acne in females cannot be used in transgender males because they interfere with hormone therapy. Androgens have been associated with the development of acne vulgaris. Recently, a topical androgen receptor inhibitor cream (clascoterone) has been FDA-approved for the treatment of acne. However, clinical trials of clascoterone have excluded participants on exogenous hormones. Clascoterone has been hypothesized to be effective in the treatment of acne in transgender male participants on masculinizing hormone therapy, but it has never been studied or reported in the literature.

Will I have to stop taking my current medications?

The trial requires you to keep your current skin care routine, including any topical or systemic medications, consistent for at least 4 weeks before joining and throughout the study. However, you cannot use topical steroids on your face during this time.

What data supports the effectiveness of the drug Clascoterone cream for treating acne?

Research shows that Clascoterone cream, especially at a 1% concentration applied twice daily, significantly reduces acne lesions and is well tolerated by patients. It works by blocking androgens, which are hormones that can cause acne, and has been proven effective in both males and females over the age of 12. ^{1 2 3 4 5}

Is clascoterone cream safe for treating acne?

Clascoterone cream has been shown to be generally safe for treating acne in people aged 12 and older. Most side effects were mild, like skin redness and dryness, and serious issues were rare. There was no significant risk of high potassium levels in the blood, and no major safety concerns were noted in studies. ^{4 6 7 8 9}

How is the drug Clascoterone cream different from other acne treatments?

Clascoterone cream is unique because it is the first topical antiandrogen treatment for acne, meaning it works by blocking male hormones (androgens) directly in the skin, unlike traditional oral treatments that affect the whole body. This makes it suitable for both males and females without the systemic side effects associated with oral antiandrogens. ^{1 2 4 6 10}

Research Team

Anne Lynn S Chang, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for transgender male patients aged 16 or older with acne that started or got worse after beginning masculinizing hormone therapy (MHT). They must have been on a stable MHT dose for at least 3 months and expect to continue the same dose. Participants need at least 20 papules or pustules and should maintain their current skin care routine throughout the study.

Inclusion Criteria

I am a transgender male or gender diverse and on hormone therapy.

I have followed a skin care routine for at least 1 month and will continue during the study.

I have 20 or more bumps or pus-filled pimples.

Exclusion Criteria

Pregnant or breast-feeding patients

I have not changed my acne treatments recently.

I can follow the study plan, attend visits, and give consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive clascoterone or placebo for acne treatment over a 3-month period

12 weeks

Monthly visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Clascoterone

Trial Overview The study tests Clascoterone, an FDA-approved cream that blocks androgen receptors, which might help treat acne caused by testosterone in transgender males on hormone therapy. It's compared against a placebo cream (vehicle) to see if it's effective when other treatments are unsuitable due to interference with hormone therapy.

Participant Groups

Group I: Clascoterone Experimental Treatment 1 Intervention

Group II: Vehicle Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

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]

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 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]

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 1% cream has been shown to significantly reduce both inflammatory and noninflammatory acne lesions in patients aged 12 and older, with a favorable safety profile observed in long-term studies lasting up to 9 months.

As a topical antiandrogen, clascoterone offers an effective alternative to systemic acne treatments, avoiding systemic side effects and making it suitable for patients who cannot use other medications due to contraindications or adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clascoterone: A Novel Topical Androgen Receptor Inhibitor for the Treatment of Acne. Kalabalik-Hoganson, J., Frey, KM., Ozdener-Poyraz, AE., et al.[2021]

Clascoterone cream 1% has been shown to be safe and effective for treating acne vulgaris in patients aged 12 years and older, maintaining its efficacy over a long-term period of up to 12 months, as demonstrated in a study with 600 participants.

The treatment resulted in significant improvements, with nearly 49% of patients achieving clear or almost clear skin by the end of the study, while the incidence of treatment-emergent adverse events was relatively low at 18.1%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Safety and Efficacy of Twice-Daily Topical Clascoterone Cream 1% in Patients Greater Than or Equal to 12 Years of Age With Acne Vulgaris. Eichenfield, LF., Hebert, AA., Gold, LS., et al.[2023]

Clascoterone cream 1% is an effective treatment for acne vulgaris in patients aged 12 and older, with clinical studies showing safety in subjects as young as nine.

While there were instances of elevated blood potassium levels (hyperkalemia) in both clascoterone and vehicle-treated patients, these were not considered adverse events and did not require monitoring, indicating a favorable safety profile for the medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There a Clinically Relevant Risk of Hyperkalemia with Topical Clascoterone Treatment? Del Rosso, J., Stein Gold, L., Squittieri, N., et al.[2023]

Topical clascoterone cream significantly improves treatment success rates in acne vulgaris, with a risk ratio of 2.87, indicating it is much more effective than placebo in achieving treatment goals.

The cream also effectively reduces noninflammatory lesion counts without increasing the risk of serious adverse events, and it is associated with a lower incidence of nasopharyngitis compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of topical clascoterone cream for treatment of acne vulgaris: A systematic review and meta-analysis of randomized placebo-controlled trials. Alkhodaidi, ST., Al Hawsawi, KA., Alkhudaidi, IT., et al.[2021]

Topical clascoterone cream 1% is the first approved topical anti-androgen treatment for acne vulgaris, showing significant effectiveness in two phase III clinical trials involving patients aged 12 and older with moderate-to-severe acne.

Clascoterone works by inhibiting androgen receptors in the skin, specifically targeting the causes of acne without systemic side effects, making it a safer option compared to traditional systemic antiandrogen medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual Article: Clascoterone Cream 1%: Mechanism of Action, Efficacy, and Safety of a Novel, First-in-Class Topical Antiandrogen Therapy for Acne. Peterson, H., Kircik, L., Armstrong, AW.[2023]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Clascoterone for treatment of acne. [2023]

2. England pubmed.ncbi.nlm.nih.gov

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

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

Clascoterone: First Approval. [2022]

4. 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]

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

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

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

Clascoterone: A Novel Topical Androgen Receptor Inhibitor for the Treatment of Acne. [2021]

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

Long-Term Safety and Efficacy of Twice-Daily Topical Clascoterone Cream 1% in Patients Greater Than or Equal to 12 Years of Age With Acne Vulgaris. [2023]

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

Is There a Clinically Relevant Risk of Hyperkalemia with Topical Clascoterone Treatment? [2023]

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

Efficacy and safety of topical clascoterone cream for treatment of acne vulgaris: A systematic review and meta-analysis of randomized placebo-controlled trials. [2021]

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

Individual Article: Clascoterone Cream 1%: Mechanism of Action, Efficacy, and Safety of a Novel, First-in-Class Topical Antiandrogen Therapy for Acne. [2023]