Clinical trial NCT06403501: Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Lead sponsor: Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-08
Enrollment: 692
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the safety and efficacy of clascoterone cream, 1%, versus the vehicle cream applied twice daily for 12 weeks in subjects with facial acne vulgaris.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with facial acne vulgaris (which includes the nose) from moderate to severe, has an Investigator's Global Assessment (IGA) score of 3 or 4; with at least 30 to a maximum of 75 inflammatory lesions (papules, pustules, and nodules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones);
* Male or female, 12 years of age or older;
* Subjects aged 18 years or older are required to provide informed consent and sign the written informed consent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of consent signing.

Exclusion Criteria:

* Subject has greater than two (2) facial nodules;
* Subject has any skin pathology or condition that could interfere with the investigator's clinical evaluation of the investigational drug;
* Subject has used topical and systemic anti-acne medications or therapies;
* Subject has received hormonal therapy for acne treatment;
* Subject has used a skincare product with acne removal effect;
* Subject has other serious underlying diseases such as mental illness or malignant tumors;
* Subject has any of the clinically significant laboratory test indicators at screening;
* Subject has known hypersensitivity or previous allergic reaction to multiple drugs, or any of the active or inactive components of the test articles;
* Subject engaged in drug abuse or excessive alcohol intake;
* Subject has uncontrolled hypertension; Subject has poorly controlled diabetes;
* Subject is pregnant, lactating, or is planning to become pregnant during the study (both male and female); subject has positive pregnancy test result; subject is unable to practice highly effective contraception methods during the trial and within 3 months after the end of the trial;
* Subject is currently enrolled or was enrolled in other clinical trials within 3 months prior to the initiation of treatment;
* Subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this clinical trial.

Primary outcomes:
measure: Percentage of Participants Achieving Success in Investigator's Global Assessment (IGA)
timeFrame: Week 12
measure: Change From Baseline in Non-inflammatory Lesion (NIL) Counts
timeFrame: Week 12
measure: Change From Baseline in Inflammatory Lesion (IL) Counts
timeFrame: Week 12
Secondary outcomes:
measure: Change From Baseline in Total Lesion Counts
timeFrame: Week 12
measure: Percent Change From Baseline in Total Lesion Counts
timeFrame: Week 12
measure: Percent Change From Baseline in Inflammatory Lesion Counts
timeFrame: Week 12
measure: Percent Change From Baseline in Non-inflammatory Lesion Counts
timeFrame: Week 12
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
Study officials:
References: