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

  • STATUS
    Recruiting
  • participants needed
    692
  • sponsor
    Zhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
Send
Updated on 24 January 2025
See if I qualify

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.

Details
Condition Acne Vulgaris
Age 12years or above
Clinical Study IdentifierNCT06403501
SponsorZhejiang Sunshine Mandi Pharmaceutical Co.,Ltd.
Last Modified on24 January 2025

Eligibility

 Yes No Not Sure

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.