Clascoterone Cream for Acne
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a cream called clascoterone, expected to reduce acne by lowering sebum production, an oily substance that acne-causing bacteria thrive on. The goal is to evaluate the cream's effectiveness in reducing sebum and treating acne. Ideal participants have mild to moderate acne with a specific number of blemishes and are willing to use only the study's products on their face. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for more patients, offering participants a chance to contribute to broader acne treatment knowledge.
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking certain medications before joining the trial. Specifically, you must not have used prescription acne medications, certain antibiotics, or topical treatments on your face for at least one month before starting the trial. Additionally, you should not use over-the-counter topical medications on your face for two weeks before the trial.
What is the safety track record for clascoterone cream 1%?
Research has shown that clascoterone cream 1% is generally safe for treating acne. In previous studies, both men and women used the cream for up to a year without major safety issues.
Some individuals experienced mild skin irritation, such as itching, burning, redness, or peeling. These effects were usually mild and localized to the application area. The cream is recommended for people aged 12 and older because its safety for younger children remains unconfirmed.
The FDA has already approved the cream for acne, indicating its safety for this use. However, if any irritation occurs, informing a doctor is important.12345Why are researchers enthusiastic about this study treatment?
Clascoterone cream is unique because it targets acne in a new way by blocking androgen receptors in the skin. Unlike traditional acne treatments like benzoyl peroxide or salicylic acid, which focus on reducing bacteria or exfoliating the skin, clascoterone tackles the hormonal aspect of acne, which can be a key factor in its development. Researchers are excited about this treatment because it offers a novel approach that could potentially provide relief for those who haven't responded well to other treatments, with fewer systemic side effects.
What is the effectiveness track record for Clascoterone Cream 1% in treating acne?
Research has shown that clascoterone cream 1% effectively treats acne. In studies, participants who used the cream for 12 weeks were more likely to see improvement compared to those using a placebo. Specifically, 18.4% to 20.3% of those using clascoterone experienced improvement, while only 6.5% to 9.0% of those using the placebo did. The cream also reduced oily skin, decreasing oiliness by 40% after 12 weeks. Overall, clascoterone cream lessens acne severity and is generally well-tolerated by users.678910
Are You a Good Fit for This Trial?
This trial is for individuals with acne, aiming to test if Clascoterone Cream 1% can reduce skin oil production. Participants should have a diagnosis of acne and be willing to apply the cream as directed.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants apply clascoterone cream 1% to evaluate its effect on sebum reduction
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Clascoterone Cream 1%
Trial Overview
The study tests Clascoterone Cream 1%, an FDA-approved medication for acne that may work by reducing sebum (skin oil) production, which could starve and kill the bacteria responsible for acne.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sun Pharmaceutical Industries Limited
Lead Sponsor
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
Citations
Real-World Experience of Clascoterone Cream 1% in Acne ...
Clascoterone cream 1% was effective and well tolerated regardless of acne severity, age, gender, and ethnicity. Clascoterone led to clinical ...
Clascoterone (Winlevi) for the Treatment of Acne
After 12 weeks of treatment, the likelihood of treatment success was greater in both studies (18.4% vs. 9.0% with vehicle in study 1 and 20.3% vs. 6.5% with ...
3.
healio.com
healio.com/news/dermatology/20241030/data-showcase-efficacy-of-winlevi-as-acne-treatmentData 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 ...
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.
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 ...
Safety & Tolerability | WINLEVI® (clascoterone) cream 1% for ...
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.
Caregiver Information | WINLEVI® (clascoterone) cream 1%
WINLEVI was found to be safe and effective in clinical trials. Safety data is based on use in FEMALE and MALE patients who used WINLEVI for up to 12 months.
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.
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, ...
Important Safety Information
WINLEVI cream may cause local skin irritation including itching, burning, skin redness or peeling. symptoms of a disorder where the adrenal gland does not make ...
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