Efficacy and Safety of Clascoterone Cream 1% in Facial Acne Vulgaris

Launched by ZHEJIANG SUNSHINE MANDI PHARMACEUTICAL CO.,LTD. · May 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new cream called clascoterone cream 1% to see how well it works and how safe it is for treating facial acne vulgaris, which is a common skin condition. The trial lasts for 12 weeks, during which participants will apply the cream or a similar cream that does not contain the active ingredient (called a "vehicle cream") to their face twice a day. The goal is to find out if clascoterone cream can help reduce acne better than the vehicle cream.

To join the study, participants need to be at least 12 years old and have been diagnosed with moderate to severe facial acne. They should have a certain number of specific types of acne lesions on their face. However, there are some reasons a person might not be eligible, such as having certain skin conditions, using other acne treatments, or being pregnant. If someone decides to participate, they can expect regular check-ins with the study team to monitor their progress and any side effects. This trial is currently recruiting participants of all genders.

Gender

ALL

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.