Clascoterone Cream for Acne

Overseen By Xiaochen 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cream called clascoterone to treat acne caused by testosterone in transgender males or gender-diverse patients on hormone therapy. The goal is to find a treatment that does not interfere with their hormone therapy, unlike many current treatments. Participants will receive either the clascoterone cream or a placebo (a cream without active ingredients) to evaluate its effectiveness. The trial seeks transgender males or gender-diverse individuals with at least 20 acne spots on their face who have been on a stable dose of masculinizing hormone therapy for at least three months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.

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.

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

Studies have shown that clascoterone cream is generally well-tolerated. Most users reported mild side effects, such as skin redness, itching, and dryness, occurring in about 7% to 12% of cases. Some also experienced swelling and a stinging sensation. Importantly, the FDA has approved clascoterone for treating acne in individuals aged 12 and older, indicating it has passed several safety checks. However, researchers have not yet specifically studied it in transgender males on hormone therapy. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for acne?

Clascoterone cream is unique because it targets the androgen receptors in the skin, which play a key role in acne development. Unlike traditional acne treatments that often rely on antibiotics or retinoids, clascoterone offers a novel mechanism by blocking hormones that contribute to acne without affecting hormone levels throughout the body. This targeted approach can potentially reduce side effects and provide an effective option for those who haven't responded well to existing therapies. Researchers are excited because it offers a fresh strategy for tackling acne with potentially quicker results and fewer systemic effects.

What evidence suggests that clascoterone cream might be an effective treatment for testosterone-induced acne?

Studies have shown that clascoterone cream effectively treats acne. In trials with over 1,400 patients, those with moderate to severe acne experienced better results with clascoterone than with a placebo cream. In this trial, participants will receive either clascoterone cream or a placebo cream. Another study found that clascoterone cream cleared about 80% of acne when used alongside another treatment. Clascoterone works by blocking certain hormones linked to acne. Although researchers have not specifically tested it on transgender males undergoing hormone therapy, its mechanism suggests it could help with acne caused by testosterone. ^{5 6 7 8 9}

Who Is on the Research Team?

Anne Lynn S Chang, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7177662/

Efficacy and Safety of Topical Clascoterone Cream, 1%, for ...

Results of the studies showed positive efficacy outcomes for clascoterone cream, 1%, compared with vehicle, with statistically significant ...

2.

aafp.org

aafp.org/pubs/afp/issues/2021/0700/p93.html

Clascoterone (Winlevi) for the Treatment of Acne

Two randomized controlled studies that included a total of 1,440 patients with moderate to severe acne demonstrated an increased treatment success rate and a ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11760757/

Real-World Experience of Clascoterone Cream 1% in Acne ...

They experienced marked improvement in their acne following the initiation of clascoterone and tazarotene, with approximately 80% clearance ...

4.

valueinhealthjournal.com

valueinhealthjournal.com/article/S1098-3015(23)00298-X/fulltext

CO125 Efficacy of Clascoterone Cream 1% for up to 12 ...

Clascoterone cream 1% maintained a favorable efficacy profile for up to 12 months in patients aged ≥9 years with acne vulgaris.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06403501

Efficacy and Safety of Clascoterone Cream 1% in Facial ...

The primary objective of this study is to determine the safety and efficacy of clascoterone cream, 1%, versus the vehicle cream applied twice daily for 12 ...

6.

winlevi-hcp.com

winlevi-hcp.com/safety-and-tolerability

Safety & Tolerability | WINLEVI® (clascoterone) cream 1% for ...

Most common adverse reactions, occurring in 7% to 12% of patients are erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and ...

7.

winlevi.com

winlevi.com/important-safety-information

Important Safety Information

WINLEVI (clascoterone) cream 1% is a prescription medicine used on the skin (topical) to treat acne vulgaris in people 12 years of age and older.

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32320027/

Efficacy and Safety of Topical Clascoterone Cream, 1%, for ...

Use of clascoterone cream, 1%, for acne treatment appears to demonstrate favorable efficacy and safety with low adverse event rates.

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accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2020/213433s000lbl.pdf

WINLEVI® (clascoterone) cream, for topical use

Safety and effectiveness of WINLEVI cream for the topical treatment of acne vulgaris have been established in 641 pediatric patients, aged 12 to 18 years in two ...