None listed
Conditions
Interventions
Intervention1: Ichthraletten®
: During the 1st and the 2nd treatment week, 2 tablets are taken unchewed 3 x daily (morning, afternoon, night) with a glass of lukewarm water before meals.
During the 3rd to 12th treatment week, 1 t
Sponsors
ICHTHYOLCompany Cordes Hermanni and Co
Eligibility
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 >Diagnosis: mild to moderate acne papulopustulosa in the area of the face, level 2 ? 3 referring to GAAS. >Safe contraception
Exclusion criteria
Exclusion criteria: >Acne resulting from medicine , steroid acne, halogen acne, acne-like dermatitis >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 >Fructose-intolerance, lactase-deficiency, saccharase-isomaltase-deficiency, glucose-galactose-malabsorption >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 3 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 |
|---|---|
| Global Acne Assessment Score (GAAS)Timepoint: 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| A. The proof of superiority of Ichthraletten enteric-coated tablets as compared to placebo with reference to reduction of number of inflammatory efflorescences (papules/pustules) in case of mild to moderate acne papulopustulosa. B. The proof of superiority of Ichthraletten enteric-coated tablets as compared to placebo with reference to reduction of number of non-inflammatory efflorescences (comedones) in case of mild to moderate acne papulopustulosa. Timepoint: 12 weeks. | — |
Countries
India
Contacts
Public ContactDr Vimla DSouza
Asiatic Clinical Research Pvt. ltd.
Outcome results
None listed