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 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT02575950
Eligibility Criteria:
Inclusion Criteria:
* Subjects should be diagnosed with acne vulgaris of the face
* Fitzpatrick skin types I-III (due to lack of safety data for the investigational product in darker skin types)
* Disease severity and total lesion count should be similar in both TAs
* Disease severity grade as moderate to severe according to the investigator's global assessment (grade 3-4)
* Age 18 to 35 years incl.
* Male or female
* Female Subjects must be of either non-childbearing potential or child-bearing potential with a confirmed negative pregnancy test
Exclusion Criteria:
* Subjects with nodulocystic acne, acne conglobata, acne fulminans, secondary acne (e.g. chlor-acne, drug-induced acne)
* Subjects with previous history of keloid formation or post-inflammatory hyperpigmentation
* Systemic retinoids within 12 month or systemic antibiotics within 1 month before Day 1
* Topical retinoids within 3 months before Day 1 or other topical treatments and/or medicated products and cosmetics that in the opinion of the investigator may influence the subjects acne vulgaris (including soaps containing antibacterial agents such as benzoyl peroxide, keratinolytic agents such as salicylic acid, skin fresheners/astringents or aftershave products) within 1 month before Day 1
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT02575950
Study Brief:
Protocol Section:
NCT02575950