To prove the therapeutic efficacy and tolerability of Ichthraletten® versus placebo in case of mild to moderate Acne papulopustulosa.
- Registration Number
- CTRI/2009/091/000791
- Lead Sponsor
- ICHTHYOLCompany Cordes Hermanni and Co
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
>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 a legal representative
>Diagnosis: mild to moderate acne papulopustulosa in the area of the face, level 2 ? 3 referring to GAAS.
>Safe contraception
>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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Global Acne Assessment Score (GAAS)Timepoint: 12 weeks.
- Secondary Outcome Measures
Name Time Method 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. <br/ ><br>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. <br/ ><br>Timepoint: 12 weeks.