Double-blind, randomized, vehicle-controlled, multi-centric trial to prove the therapeutic efficacy and tolerability of a liquid acne topical containing Clindamycin phosphate and Sodiumbituminosulfonate, pale versus vehicle and versus each of the single active substances in mild to moderate acne vulgaris - liquid acne topical in mild to moderate acne vulgaris
- Conditions
- mild to moderate acne vulgaris
- Registration Number
- EUCTR2009-013273-17-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
·Male or female patients between 10 and 45 years
·Voluntary participation in the study
·Availability of signed consent form of patients, in case of patients < 18 years in addition with the signature of both legal representatives
·Diagnosis: mild to moderate acne vulgaris in the area of the face, level 2 – 3 referring to GAAS
·Safe contraception (female patients)
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
·Acne resulting from medicine , steroid acne, halogen acne, acne-like dermatitis
·Serious form of acne (for example acne conglobata)
·Serious supplementary diseases (e.g. liver-/renal function disturbances, metabolic diseases, tumours in anamnesis)
·Existence of an disease that demands systemic and/or topical antibiotics- or steroid-administration
·Systemic pre-treatment with isotretinoin
·Oral and/or topical therapy with antibiotics, anti-androgens (apart from safe contraception), corticosteroids, retinoids, azelaic acid, salicylic acid or benzoyl peroxide before or during the study (previous topical therapy must end at least 2 weeks before admission to the study and an oral therapy at least 4 weeks before admission to the study!)
·Application of other medicinal products which can affect the course of disease or the therapy during the study
·Application of any cosmetic products in the face during the study period
·Known allergy towards substances of investigational medicinal product
·Alcohol-, drugs- or medication abuse
·Physical or psychological diseases in case of which the adherence of study protocol appears to be doubtful
·Inadequate compliance
·Pregnancy, lactation
·First time application of hormonal contraceptives or change of contraceptives within the last 6 months
·Participation in a clinical study within the last 30 days, planned participation in a clinical study during the course of this study
·Previous participation in this study
·Participation of another family member in this study
·Pre-treatment with the study medication
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method