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 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
NCT ID:
NCT00907335
Eligibility Criteria:
Inclusion Criteria:
* Males and non-pregnant, non-nursing females, 9 to 11 years, with facial pediatric acne vulgaris
* Minimum of 20 non-inflammatory lesions (open and closed comedones)
* Minimum of 30 total facial lesions (sum of inflammatory and non-inflammatory)
* Must have at least a rating of grade 3 on the Investigator Global Assessment Scale for acne severity (IGA #1) at baseline
Exclusion Criteria:
* Known sensitivity to any of the ingredients in the study medication;
* Any nodulocystic acne lesions
* Use of acne devices or systemic therapy with antibiotics within two months prior to start and throughout the duration of the study
* Use of systemic therapy with retinoids within four months prior to study start and throughout the duration of the study
* Topical use of topical retinoids within two weeks prior to study start and throughout the duration of the study
* Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study
* Use of an experimental drug or device within 60 days prior to study start;
* Use of hormonal therapy within 3 months prior to study start
* History of evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication
* Any significant medical conditions that could confound the interpretation of the study
* History of/or current facial skin cancer
* Inability to refrain from use of all facial products other than those supplied by the study, while participating in the study
* No use of tanning booths, sun lamps, etc.
* Subject is a family member of the employee or the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Maximum Age:
11 Years
Study:
NCT00907335
Study Brief:
Protocol Section:
NCT00907335