Clascoterone Cream for Acne

Overseen By Head Clinical development

Age: 18 - 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Sun Pharmaceutical Industries Limited

Must not be taking: Topical prescriptions, OTC products

Disqualifiers: Dermatological disorders, Unstable medical disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cream called clascoterone to evaluate its effects on acne and oily skin. It aims to understand changes in the skin's oil glands and the composition of skin oil after three months of use. The trial seeks participants aged 18-35 with moderate acne, oily skin, and noticeable pores. Participants should not have facial scars, tattoos, or other skin issues and must agree to use only the study cream on their face during the trial. As a Phase 4 trial, this research helps determine how this FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial requires participants to stop using any topical prescription products on the face for 4 weeks and any over-the-counter products for 2 weeks before joining. It doesn't specify about other medications, but you must agree to use only the study product on your face during the trial.

What is the safety track record for Clascoterone cream?

Research has shown that clascoterone cream 1% is generally safe for treating acne in individuals aged 12 and older, and it is already approved for this use. Some individuals might experience skin irritation, such as itching, burning, redness, or peeling. These side effects are common but usually mild. No safety information exists for children under 12. Evidence so far indicates that clascoterone is well-tolerated for its intended use in older patients. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Clascoterone cream is unique because it targets acne by blocking androgen receptors in the skin, which are hormones that can increase oil production and lead to breakouts. Unlike many current treatments like benzoyl peroxide or salicylic acid, which focus on exfoliating the skin or killing bacteria, clascoterone directly addresses the hormonal component of acne. Researchers are excited about this treatment because it offers a new approach, potentially reducing the reliance on systemic treatments like oral antibiotics or hormonal therapies that come with more significant side effects. This topical solution could provide effective relief with fewer side effects, making it a promising option for patients.

What is the effectiveness track record for Clascoterone cream in treating acne?

Research shows that clascoterone cream 1% effectively treats acne. Studies have found it can clear up to 80% of acne when combined with other treatments. One study found that by week 12, it reduced oily skin by 40%. It also helps clear skin and prevent future breakouts. Overall, many studies have proven its success in reducing acne severity and improving skin condition. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with acne. Specific details about eligibility criteria are not provided, but typically participants must have a certain severity of acne and be in good general health.

Inclusion Criteria

Subjects have signed an Informed Consent Form in compliance with 21CFR Part 50: 'Protection of Human Subjects'

I am in good physical and mental health.

Subjects of all Fitzpatrick skin types

Exclusion Criteria

I don't have skin conditions that could affect skin evaluation.

I am willing to use the study product on my face as instructed.

Subjects who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Clascoterone cream 1% for 3 months to assess changes in sebaceous gland morphology and sebum constituents

12 weeks

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 is testing the effects of Winlevi (Clascoterone) cream at 1% concentration on facial sebaceous glands and the composition of facial sebum after three months of treatment.

How Is the Trial Designed?

Group I: Winlevi (Clascoterone ) cream 1% Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Sun Pharmaceutical Industries Limited

Lead Sponsor

Trials

71

Recruited

14,000+

Dilip Shanghvi

Sun Pharmaceutical Industries Limited

Chief Executive Officer since 1993

Majored in Cellular and Molecular Biology at the University of Michigan – Ann Arbor

Dr. Azadar H. Khan

Sun Pharmaceutical Industries Limited

Chief Medical Officer since 2023

MD from a recognized institution

Published Research Related to This Trial

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]

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 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 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 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 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 (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 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]

Citations

1. 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 ...

2. healio.com healio.com/news/dermatology/20241030/data-showcase-efficacy-of-winlevi-as-acne-treatment

Data showcase efficacy of Winlevi as acne treatment Winlevi reduced the appearance of an oily face by 8% (P = .008) at week 4 and 40% (P < .001) by week 12. · When layered with other topical acne ...

3. winlevi-hcp.com winlevi-hcp.com/efficacy

Efficacy | WINLEVI® (clascoterone) cream 1% for HCPs WINLEVI leads to clearer skin and helps control future breakouts · TREATMENT SUCCESS IN DETAIL · Lesion count at Week 12 · Focus on before-and-after results.

4. 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 ...

5. acneandrosacea.org acneandrosacea.org/blog/winlevi-suitable-for-use-in-topical-combination-therapy-poster-data/

Winlevi Suitable for Use in Topical Combination Therapy Winlevi (clascoterone, Sun Pharma) Cream 1% significantly reduces sebum production, reduces acne severity while providing tolerability for patients with skin ...

6. winlevi-hcp.com winlevi-hcp.com/safety-and-tolerability

Safety & Tolerability | WINLEVI® (clascoterone) cream 1% ... WINLEVI (clascoterone) cream 1% is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

7. winlevi-hcp.com winlevi-hcp.com/important-safety-information

Important Safety Information | WINLEVI® (clascoterone) cream ... WARNINGS AND PRECAUTIONS. Local Irritation: Pruritus, burning, skin redness or peeling may be experienced with WINLEVI cream. If these effects occur, ...

8. 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.

9. 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 has not been established in pediatric patients under 12 years of age.

10. mayoclinic.org mayoclinic.org/drugs-supplements/clascoterone-topical-application-route/description/drg-20502460

Clascoterone (topical application route) - Side effects & ... However, safety and efficacy of clascoterone cream have not been established in children younger than 12 years of age.