EUCTR2015-002699-26-DEActive, not recruitingNot Applicable
Pilot study of 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).
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- GWT-TUD GmbH
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
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 childbreaking years except
- •post-menopausal (12 Monate natürliche Amenorrhoe),
- •? postoperative (6 weeks after ovariectomy with or without hysterectomy)
- •-regulary and correct use of contraceptive with error rate < 1 %/year
- •- 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
Investigators
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