• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What are Clinical Trials?
    • Become a Clinical Trial Volunteer
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Winlevi (clascoterone)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Winlevi (clascoterone)

  • Profile

Profile

Contact Information

Contact: Cassiopea
Website: https://www.winlevi.com/

Currently Enrolling Trials

    Show More

    General Information

    Winlevi (clascoterone) is an androgen receptor inhibitor.

    Winlevi cream is specifically indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

    Winlevi is supplied as a cream for topical administration. Cleanse the affected area gently. After the skin is dry, apply a thin uniform layer of Winlevi cream twice per day, in the morning and the evening, to the affected area. Avoid accidental transfer of Winlevi cream into eyes, mouth or other mucous membranes. If contact with mucous membranes occurs, rinse thoroughly with water.

    Mechanism of Action

    Winlevi (clascoterone) is an androgen receptor inhibitor. The mechanism of action of Winlevi cream for the topical treatment of acne vulgaris is unknown.

    Side Effects

    Adverse effects associated with the use of Winlevi may include, but are not limited to, the following:

    • erythema/reddening
    • pruritus
    • scaling/dryness
    • edema
    • stinging
    • burning

    Clinical Trial Results

    The FDA approval of Winlevi cream 1% applied twice daily for 12 weeks for the treatment of acne vulgaris were assessed in two identically-designed, multicenter, randomized, double-blind, vehicle-controlled clinical trials. The trials enrolled subjects 9 years or older with Investigator’s Global Assessment (IGA) of moderate or severe facial acne vulgaris (score of 3 or 4), 30 to 75 inflammatory lesions (papules, pustules and nodules), and 30 to 100 non-inflammatory lesions (open and closed comedones). A total of 1,421 subjects 12 years and older with facial acne vulgaris were enrolled. At baseline, subjects had a mean inflammatory lesion count of 42.4 and a mean non-inflammatory lesion count of 61.4. Additionally, approximately 83% of subjects had an IGA score of 3 (“moderate”). Efficacy was assessed at Week 12 by the proportion of subjects in each treatment group with at least a 2-point reduction in IGA compared to baseline and an IGA score of 0 (clear) or 1 (almost clear), absolute change and percent change from baseline in non-inflammatory and inflammatory lesions. IGA Success: Trial 1: 18.8% for Winlevi versus 8.7% for placebo. Trial 2: 20.9% for Winlevi versus 6.6% for placebo. At week 12, treatment with clascoterone cream 1%, resulted in a significant reduction in absolute noninflammatory lesions from baseline to −19.4 (both trials) versus −13.0 and −10.8 with placebo, respectively, as well as a reduction in inflammatory lesions from baseline to −19.3 and −20.0 versus −15.5 and −12.6 with vehicle, respectively. 

    Approval Date: 2020-08-01
    Company Name: Cassiopea
    Back to Listings

    Upcoming Events

    • 05Dec

      Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 3 – Site Resourcing

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Jonathan Seltzer

      Thought Leadership: Remote Patient Monitoring Gives New View of Safety in Cardiac Clinical Trials

    • Quality_Compass-360x240.png

      Ask the Experts: Applying Quality by Design to Protocols

    • Obesity Treatment Patient

      Clinical Trials Need Greater Representation of Obese Patients, Experts Say

    • Modernize-360x240.png

      FDA IT Modernization Plan Prioritizes Data-Sharing, AI, Collaboration and More

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing