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).
- Conditions
- acne vulgarisTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2015-002699-26-DE
- Lead Sponsor
- GWT-TUD GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the tolerability of the two acne products. The main variable ist the transepidermal water loss (TEWL);Secondary Objective: - Measuring the severity of burning/ stinging and itching using Study Subject Self-Assessment<br>-Measuring and recording the number of acneiform lesions <br>-Measuring health-related quality of life using DLQI-Score/CDLQI<br>-Measuring skin hydration using Corneometer<br>-Measuring transepidermal water loss (TEWL) using Tewameter<br>-Measuring skin surface pH using pH-Meter<br>-Measuring skin sebum excretion using Sebumeter <br>;Primary end point(s): Difference of the TEWL at the beginn of the study and after 3 weeks of product application.;Timepoint(s) of evaluation of this end point: 3 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Measuring the severity of burning/ stinging and itching using Study Subject Self-Assessment<br>-Measuring and recording the number of acneiform lesions <br>-Measuring health-related quality of life using DLQI-Score/CDLQI<br>-Measuring skin hydration using Corneometer<br>-Measuring transepidermal water loss (TEWL) using Tewameter<br>-Measuring skin surface pH using pH-Meter<br>-Measuring skin sebum excretion using Sebumeter <br>;Timepoint(s) of evaluation of this end point: 3 weeks