Pilot Study of Tolerability and Effectivity of Two Combination Topical Acne Products

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Study to compare two gels that are used to treat acne vulgaris. It will be compared the tolerability and effectivity following application of two combination topical acne products clindamycin 1% and 0.025% tretinoin gel (Acnatac® Gel), adapalen 0,1% and benzoyl peroxide 2,5% gel (Epiduo® Gel).

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GWT-TUD GmbH
• Treatments: Adapalene, Benzoyl Peroxide Drug Combination; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Tretinoin

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