Actively Recruiting
A Multicenter, Randomized, Double-Blind, Vehicle-Controlled Clinical Study to Evaluate the Efficacy and Safety of Clascoterone Cream 1% in Treatment of Subjects With Facial Acne Vulgaris
Led by Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd. · Updated on 2025-07-09
692
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Clascoterone Cream 1% compared to a placebo cream for treating moderate to severe facial acne vulgaris. This study is a phase 3, randomized, double-blind clinical trial aimed at determining how well Clascoterone Cream works in reducing acne lesions and improving the Investigator's Global Assessment score over 12 weeks. Participants will be randomly assigned to receive either Clascoterone Cream 1% or a vehicle cream that looks and feels like the active treatment but contains no active ingredients. Both creams are applied twice daily for 12 weeks. The study groups include an experimental arm using Clascoterone Cream and a placebo comparator arm using the vehicle cream. During the 12-week study, participants will undergo regular evaluations of their acne, including counts of inflammatory and non-inflammatory lesions and overall lesion counts. The main outcomes measured are the percentage of participants achieving success in the Investigator's Global Assessment and changes in lesion counts from baseline. Safety and adherence will be monitored throughout the trial, and participants will be followed until the study ends in October 2026.
CONDITIONS
Brief Title
Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with moderate to severe facial acne vulgaris including the nose, with an Investigator's Global Assessment (IGA) score of 3 or 4
- Have 30 to 75 inflammatory lesions (papules, pustules, and nodules)
- Have 30 to 100 non-inflammatory lesions (open and closed comedones)
- Male or female, 12 years of age or older
- Participants 18 years or older must provide informed consent; those under 18 must provide assent and have parental or guardian consent
You will not qualify if you...
- More than two (2) facial nodules
- Any skin condition that could interfere with clinical evaluation of the study drug
- Recent use of topical or systemic anti-acne medications or therapies
- Received hormonal therapy for acne treatment
- Use of skincare products with acne removal effects
- Serious underlying diseases such as mental illness or malignant tumors
- Clinically significant abnormal laboratory test results at screening
- Known hypersensitivity or allergic reaction to multiple drugs or study cream components
- History of drug abuse or excessive alcohol intake
- Uncontrolled hypertension or poorly controlled diabetes
- Pregnant, lactating, planning pregnancy during the study, or unable to use effective contraception
- Participation in other clinical trials within 3 months prior to treatment
- Any condition making participation unsafe in the investigator's opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants apply Clascoterone Cream 1% or Vehicle cream to treat facial acne vulgaris.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Huashan Hospital, Fudan University
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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