Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
NCT ID:
NCT03122457
Eligibility Criteria:
Inclusion Criteria:
* Women 18 years or older
* Women who have had their first menses at least 12 months ago, and who currently have regular menses.
* Subjects must be able to read and understand English, and be able and willing to complete the survey.
* Subjects must have a self-reported complaint of peri-menstrual acne which has occurred monthly for the last 6 months.
* Subjects must be willing to forego any other therapy to the treatment area for the duration of the study.
* Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and to comply with all study requirements including concomitant medication and other treatment restrictions.
* Subjects must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.
* Subjects must be willing to use a form of birth control during the study. For the purpose of this study, the following are considered acceptable methods of birth control: oral contraceptives, Norplant, Depo-Provera, double barrier methods (e.g., condom and spermicide) and abstinence.
Exclusion Criteria:
* Male subjects.
* Post-menopausal women.
* Women who do not suffer from acne.
* Subjects who are allergic to clindamycin, benzoyl peroxide, lidocaine or any other ingredients listed in the study medication.
* Subjects with an unstable medical condition as deemed by the clinical investigator.
* Subjects with ulcerative colitis or Crohn's disease.
* Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of acne.
* Women who are pregnant, lactating, or planning to become pregnant during the study period.
* Subjects who have used any topical prescription medications on the study area within 30 days prior to Visit 2 / Baseline.
* Subjects on a stable dose of oral contraceptives for less than 6 months.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03122457
Study Brief:
Protocol Section:
NCT03122457