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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT06841393
Eligibility Criteria:
Inlcusion criteria:
Criteria related to the population:
* Subject aged between 18 and 30 years included
* For women of childbearing potential: use of an effective method of contraception, as assessed by the investigator, introduced and unchanged for at least 3 months before inclusion in the study
Criteria related to diseases:
Specific for acne group:
• Subject with acne lesions on the face, with a Global Acne Evaluation (GEA) score evaluated on the face of 2 (mild) or 3 (moderate) assessed by the investigator on a 5-point scale (0, 1, 2, 3, 4, 5 with 0 = clear - no lesions and 5 = very severe)
Non-inclusion criteria:
Criteria related to the population:
* For women of childbearing potential: pregnant or breastfeeding
* Subject having received on face artificial UV exposure, excessive or prolonged exposure to natural sunlight within 4 weeks before the inclusion visit
* Subject with facial hair liable to interfere with the study assessments
Criteria related to the disease:
* Clinical signs of hormone dysfunction or hyperandrogenism
* Severe form of acne (acne conglobata, acne fulminans or nodulocystic acne) or acneiform eruptions, in the investigator's opinion
* Sunburn on the face due to excessive UV exposure
Criteria related to skin condition:
• Subject having any other dermatologic condition than acne, or characteristics (like tattoo) on the face liable to interfere with the study assessments
Specific for control group:
* Subject with significant acne lesions according to investigator assessment
* Subject having any inflammatory face dermatosis
Criteria related to treatments and/or products:
* Any surgery, chemical or physical treatment on the face in the 12 months before the inclusion visit
* Systemic isotretinoin treatment taken in the 6 months prior before the inclusion visit
* Systemic acne treatment taken in the 3 months before the inclusion visit
* Probiotics taken orally in the month before the inclusion visit
* Topical acne treatment applied to the face in the month before the inclusion visit
* Topical or Systemic Non-Steroidal Anti-Inflammatory (NSAI), corticosteroids, taken or applied to the face in the 2 weeks before the inclusion visit
* Skincare product for acne liable to interfere with the study according to investigator's assessment applied to the face in the 2 weeks before the inclusion visit
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
30 Years
Study:
NCT06841393
Study Brief:
Protocol Section:
NCT06841393