Winlevi

Acne Vulgaris
Treatment
4 Active Studies for Winlevi

What is Winlevi

ClascoteroneThe Generic name of this drug
Treatment SummaryClascoterone is a drug used to treat acne. It works by blocking the androgen receptor, stopping the signals that cause acne. Clascoterone was approved by the FDA in August 2020 to treat acne in people 12 years and older. It is also being studied as a possible treatment for hair loss related to androgens.
Winleviis the brand name
image of different drug pills on a surface
Winlevi Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Winlevi
Clascoterone
2021
1

Effectiveness

How Winlevi Affects PatientsClascoterone is a drug that works by blocking testosterone and another hormone (DHT) that can cause skin issues such as acne and hair loss. In tests, it was shown to reduce acne in a dose-dependent manner. Clascoterone mainly works at the site of application and has minimal systemic effects. In clinical trials, some people experienced decreased hormone levels in the body after two weeks of topical treatment. These levels went back to normal when they stopped taking the drug.
How Winlevi works in the bodyAcne and androgenetic alopecia are both caused by hormones called androgens. Androgens cause the skin to produce too much sebum, and can cause inflammation. Clascoterone works by blocking androgens from binding to receptors. This stops the androgens from signaling the skin to produce too much sebum or inflammation, which helps reduce acne breakouts and improve hair loss caused by androgenetic alopecia.

When to interrupt dosage

The measure of Winlevi is contingent upon the diagnosed affliction. The amount of dosage likewise changes with the approach of delivery stipulated in the accompanying table.
Condition
Dosage
Administration
Acne Vulgaris
0.01 mg/mg,
Cream - Topical, Cream, , Topical

Warnings

Common Winlevi Drug Interactions
Drug Name
Risk Level
Description
Winlevi Toxicity & Overdose RiskThe toxicity of clascoterone is unknown, including what the lethal dose would be and what would happen if someone were to overdose.
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Winlevi Novel Uses: Which Conditions Have a Clinical Trial Featuring Winlevi?

18 ongoing studies are currently evaluating the potential of Winlevi to address Acne.
Condition
Clinical Trials
Trial Phases
Acne Vulgaris
3 Actively Recruiting
Phase 1, Phase 2, Early Phase 1

Winlevi Reviews: What are patients saying about Winlevi?

5Patient Review
11/9/2022
Winlevi for Acne
I've been struggling with hormonal acne for years, but this product has finally helped clear up my skin. I'm so thankful!
5Patient Review
5/3/2022
Winlevi for Acne
This cream is nothing short of amazing. It's cleared up my acne better than any other product I've tried, and it doesn't dry out my skin like so many others have.
5Patient Review
4/9/2022
Winlevi for Acne
Winlevi cleared up my cystic acne in just three days!
5Patient Review
5/6/2022
Winlevi for Acne
This medication has done wonders for my hormonal acne. My skin looks better than it ever has, and I would highly recommend it to others suffering from a similar issue.
4.7Patient Review
2/11/2022
Winlevi for Acne
Winlevi has been an amazing treatment for my hormonal cystic acne. After a long and difficult battle with Spironolactone, I finally found something that works with zero side effects. If you're struggling like I was, definitely give this topical prescription a try.
4.7Patient Review
3/10/2022
Winlevi for Acne
I've been using Winlevi for two months now, and it's really helped with my hormonal acne. It doesn't dry out or irritate my skin the way some other treatments can, and it's just overall a great product that I would recommend to anyone struggling with similar issues.
3.7Patient Review
7/23/2022
Winlevi for Acne
I've only been using Winlevi for two weeks, but my face looks significantly worse. I'm hoping this is one of those situations where "it gets worse before it gets better," like with Tretinoin.
2.7Patient Review
9/23/2022
Winlevi for Acne
I've been using Winlevi for two months now, and my acne has never been worse. I'm in a lot of pain from it - cystic acne under my skin makes it hard to move my lips or smile. I hope my dermatologist will take me off this medication soon.
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Patient Q&A Section about winlevi

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is Winlevi used for?

"The drug WINLEVI (clascoterone) cream 1% is designed to treat acne vulgaris and is intended for use by patients who are at least 12 years old."

Answered by AI

Does Winlevi make your skin worse before better?

"The following side effects may occur: redness, itching, peeling, or dryness of the skin. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Keep in mind that your doctor prescribed this medication because they believe the benefits of the drug outweigh the risks of side effects."

Answered by AI

How quickly does Winlevi work?

"If you start using Winlevi (clascoterone), it may take up to 3 months for your skin to get better. If your acne does not start to improve right away, it might mean that the medication needs more time to work."

Answered by AI

Is Winlevi the same as spironolactone?

"The FDA just approved a new cream called Winlevi, which could replace the popular off-label use of spironolactone pills. This is the first new acne medication to be approved since Accutane (isotretinoin) in 1982. So how does it work, and what makes it so groundbreaking?"

Answered by AI

Clinical Trials for Winlevi

Image of InnovaDerm in Montreal, Canada.

PF-07905428 for Acne

18 - 40
All Sexes
Montreal, Canada
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07905428) for the potential treatment of acne vulgaris. This study is seeking participants who: * Are male or female between the ages of 18 and 40 * Are generally healthy * Are diagnosed with moderate to severe acne vulgaris (Cohort 4 only) The study medicine will be applied every day on the participant's face and/or back for 14 days (Cohorts 1 and 2) or for 28 days (Cohort 3 and 4). The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help the investigators determine if the study medicine is safe and effective. Participants will take part in this study for approximately 2 months. During this time, they will have 17 study visits (Cohorts 1 and 2) or 31 study visits (Cohorts 3 and 4) at the study clinic. The study team will also call participants once at the end of the study over the phone.
Phase 1
Waitlist Available
InnovaDerm (+2 Sites)Pfizer CT.gov Call CenterPfizer
Image of Medical University of South Carolina in Charleston, United States.

Isotretinoin vs Tetracycline for Acne

Any Age
All Sexes
Charleston, SC
In the effort to find better treatments for Moderate Acne, which often relies on long-term antibiotic use, researchers are exploring alternative options. While Isotretinoin, a Vitamin A derivative, is highly effective for severe acne, its side effects limit its use for milder cases. A recent study from our institution investigated a new approach: weekly Isotretinoin dosing. The results were promising, with acne improvement and no major side effects. This suggests that weekly Isotretinoin could be a successful alternative for moderate acne in both males and females. To validate these findings, investigators propose a randomized controlled trial comparing weekly Isotretinoin to daily Doxycycline over four months. This study could confirm the safety and effectiveness of weekly Isotretinoin, as well as shed light on patient satisfaction, and long-term results compared to standard antibiotics. This research may offer a breakthrough in treating moderate acne while addressing concerns about antibiotic overuse.
Phase < 1
Recruiting
Medical University of South CarolinaAlex Richmond, MD, MSCR
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Clascoterone Cream for Acne

Any Age
All Sexes
Stanford, CA
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.
Phase 1 & 2
Recruiting
Stanford UniversityAnne Lynn S Chang, MD
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