mild to moderate acne vulgaris
Conditions
Sponsors
Ichthyol-Gesellschaft Cordes, Hermanni & Co. (GmbH & Co.) KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ·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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The proof of superiority of the combination (A) solution as compared to vehicle and to each of the mono preparations with reference to the improvement of acne-appearance in accordance with GAAS (comparison of the score at study start and end) in case of mild to moderate acne vulgaris.;Secondary Objective: The proof of superiority of the combination (A) solution as compared to vehicle and to each of the mono preparations with reference to: a: ... achieving success based on the GAAS. Success on the 5-point scale is defined as a rating of “none” (0) or “minimal” (1). b... reduction of the number of inflammatory efflorescences (papules/pustules) in case of mild to moderate acne vulgaris. c. ... reduction of the number of non - inflammatory efflorescences (comedones) in case of mild to moderate acne vulgaris. d... the efficacy assessed by the investigator and the patient at every visit and as global assessment at the final visit. e. Comparability in tolerability as compared to vehicle and to each of the mono preparations assessed by the investigator and the patient at every visit and as global assessment at the final visit. f. Global assessment of patient subjective perception of acne impact on quality of life. g.Evaluation of the feasibility of the application of the product. ;Primary end point(s): Visit 6 = final examination after 12 weeks treatment | — |
Countries
Czech Republic, Germany
Outcome results
None listed