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:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-25 @ 2:03 AM
NCT ID:
NCT04216160
Eligibility Criteria:
Inclusion Criteria:
* Healthy skin in the test areas;
* Subjects willing and capable to follow the study rules and a fixed schedule;
* Ability of giving consent for participation in the study;
* Subjects with good health in general and good mental condition;
* Subjects who present at least 10 inflammatory lesions;
* Oily skin on the face (minimum sebumetry value 100µg/cm² on frontal area (mean: 3 measurements)).
Exclusion Criteria:
* Pregnancy or breastfeeding;
* Subjects who present severe acne;
* Subjects who present more than two nodular lesions;
* Subjects who changed their oral contraception method up to three months before the study beginning;
* Subjects who did acne hormonal treatment less than 6 months before the study;
* Subjects who did oral isotretinoïne treatment less than 1 month before the study;
* Subjects who did topical acne treatment less than 90 months before the study;
* Subjects who did aesthetic treatment less than 6 months before the study (like laser and peeling);
* Subjects who did treatment with antibiotics within the last 4 months;
* Simultaneous participation in different studies from external research institutes on the same test sites;
* Inadequate language proficiency (spoken and written);
* Participate in the study under the influence of alcohol and/or drugs as well as addiction;
* Severe psychological disease or intellectual disability of understanding the study;
* Severe disease (heart/circulatory/liver, kidney and lungs disease, severe diabetes mellitus) or chronic infections (hepatitis, HIV);
* Immune insufficiency;
* Current use of the following topical or systemic medications: corticosteroids, immunosuppressive and anti-histaminic drugs;
* Skin diseases: vitiligo, psoriasis, atopic dermatitis;
* Confirmed allergies to cosmetic components or previous responses of intolerance after the application of cosmetic products of the same category of the investigational products;
* Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
35 Years
Study:
NCT04216160
Study Brief:
Protocol Section:
NCT04216160