acne vulgaris
Conditions
Interventions
Trade Name: Acnatac® Gel
Product Name: Acnatac® Gel
Product Code: 85210.00.00
Pharmaceutical Form: Gel
Trade Name: Epiduo® Gel
Product Name: Epiduo® Gel
Product Code: 67913.00.00
Pharmaceutical For
Sponsors
GWT-TUD GmbH
Eligibility
Sex/Gender
All
Inclusion 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 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
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 -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 -Measuring and recording the number of acneiform lesions -Measuring health-related quality of life using DLQI-Score/CDLQI -Measuring skin hydration using Corneometer -Measuring transepidermal water loss (TEWL) using Tewameter -Measuring skin surface pH using pH-Meter -Measuring skin sebum excretion using Sebumeter ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Measuring the severity of burning/ stinging and itching using Study Subject Self-Assessment -Measuring and recording the number of acneiform lesions -Measuring health-related quality of life using DLQI-Score/CDLQI -Measuring skin hydration using Corneometer -Measuring transepidermal water loss (TEWL) using Tewameter -Measuring skin surface pH using pH-Meter -Measuring skin sebum excretion using Sebumeter ;Timepoint(s) of evaluation of this end point: 3 weeks | — |
Countries
Germany
Contacts
Public ContactPI Roland Aschoff
Klinik und Poliklinik für Dermatologie, Universitätsklinikum Carl Gustav Carus an der TU Dresden
Outcome results
None listed