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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT02731105
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of mild to moderate facial acne vulgaris at baseline
* Age: 14 years to 50 years
* No evidence of facial irritation (erythema, dryness/scaling, burning/itching/stinging) that is not typical for acne vulgaris
* Willingness to take part in acne study including screening visit and follow up visits on day 0,7, and 21
* No use of systemic antibiotics, steroids, retinoids and keratolytics within the last 30 days before start of the acne study
* Patients have to sign personally consent form and follow study procedures
* Patient is in good general health
Exclusion Criteria:
* Female patients who were pregnant, planning to become pregnant or breastfeeding
* Sexually active female subjects do not use a medically acceptable form of contraception (oral contraception, injectable or implantable methods or intrauterine devices)
* Female patients who are in childbearing years except post-menopausal (12 month natural amenorrhoea),
▪ postoperative (6 weeks after ovariectomy with or without hysterectomy)
* regularly and correct use of contraceptive with error rate \< 1 %/year
* no sex
* vasectomy of the partner
* Diseases of the facial skin other than acne
* No concomitant topical medications (including make-up) or keratolytics as sulphur, salicylic acid, benzoyl peroxide, resorcin and abradents and acid-containing peels one week before the study starts
* Patients who had facial procedures (chemical peel, laser therapy, photodynamic therapy, microdermabrasion, or UV light therapy) within the past 4 weeks
* No concomitant participation in other studies within the past 30 days
* Hypersensitivity against any ingredients of Acnatac® -gel or Epiduo®gel
* Systemic medication with antibiotics or antibiotics within the last 4 weeks before study start
* Systemic medication with retinoids within the last 6 months before study start
* Topical treatment of acne vulgaris within the last two weeks before study
* Acne fulminans,
* Severe systemic disease respectively taking immunosuppressive drugs
* Severe liver disease
* Severe renal disease
* History or presence of regional enteritis or inflammatory bowel disease
* Other reasons that the doctor in charge decides about
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
50 Years
Study:
NCT02731105
Study Brief:
Protocol Section:
NCT02731105