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%
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