Patients aded 18 and older suffering from papulopustular rosacea (subtype II) or moderate phymateous rosacea (moderate subtype III) with a minimum grade 4 in the 'Global physicians's assessment score - Rosacea' (= Half of the face centrofacial and frontal covered with small papules. Some pustules or prominent papules/noduli, edema and strong erythema, telangiectasia) and a minimum of 8 inflammatory lesions.
Conditions
Interventions
Trade Name: Aknenormin 10 mg Weichkapseln
Product Name: Isotretinoin
Product Code: 10033002
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Isotretinoin
CAS Number: 4759-48-2
Current Sponsor c
Sponsors
Almirall Hermal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · the written informed consent form has been signed and dated · papulopustular rosacea (rosacea subtype II) or moderate phymatous rosacea (moderate rosacea subtype III) · a minimum grade 4 in the “Global physician’s assessment score – Rosacea” · at least 8 inflammatory lesions · existence of rosacea for at least three months prior to inclusion · age 18 years or older · body weight between 50 kg and 130 kg · high probability of a good compliance and orderly completion of the study FOR FERTILE WOMEN ONLY · medically controlled, negative pregnancy test within the first 3 days of the actual menstrual cycle in all women except those who were surgically sterile or at least one year postmenopausal. Are the trial subjects under 18? no 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: · advanced phymatous rosacea, where phyma in particular rhinophyma is indicated for surgical therapy at the discretion of the investigator · exclusively ocular rosacea · nodular rosacea · erythematotelangiectatic rosacea · severe facial skin dryness or xerosis · known keratoconjunctivitis sicca · known Sjögren’s syndrome · the topical use of any medication that may influence rosacea (e.g. metronidazole, azelaic acid, adapalene or antibiotics) within the last 2 weeks proir to treatment start · the systemic use of metronidazole within the last 6 weeks prior to study start · systemic antibiotic treatment within the last 6 weeks prior to treatment start – particularly tetracycline · need for concomitant antibiotic treatment (except study indication) · corticoid treatment within the last month prior to treatment start (exception: inhalation with corticosteroids in subjects with asthma will be allowed at a dose not exceeding 1 mg/day; the dosage should remain consistent throughout the entire study period) · need for corticoid treatment (exception: see above) · isotretinoin treatment within the last 6 months prior to treatment start · use of drugs that can increase sensitivity towards light, e.g. Saint-John’s-wort (hypericum preparations) · use of drugs or food supplements containing Vitamin A or ß-carotin · known or suspected depression or psychosis, either present or in medical history · known or suspected mental or neurological disorders (e.g. dementia, Alzheimer’s disease, Parkinson’s disease) · history of malignoma · known or suspected gastric or intestine ulcera · known or suspected pancreatitis · known or suspected oesophagitis · known or suspected HIV · known or suspected hypervitaminosis A · acute nausea and/or diarrhoea · liver enzymes (AST, ALT, and ?-GT) higher than 2 fold upper limits of normal (ULN)* · triglycerides higher than 1.5 fold upper limits of normal (ULN)* · cholesterol higher than 1.5 fold upper limits of normal (ULN)* · pregnant or breast-feeding women · participation in another clinical trial within 30 days directly preceding the administration of the study drug · simultaneous participation in another clinical trial · any suspicion of drug and/or alcohol abuse · clinical history suggestive of intolerance or allergy to one of the products · any chronic disease that may affect the absorption, metabolism or elimination of the investigational product * = based on screening blood sampling FOR FERTILE WOMEN ONLY · fertile women without hormonal contraception during the last menstrual cycle prior to study start and/or not willing to accept the continuation of this hormonal contraception (combination oral contraceptive, hormonal patch, hormonal implants, hormonal injections, IUD – hormonal intra uterine device) during the entire study and for at least 35 days after end of treatment · fertile women not willing to accept two established and reliable methods of contraception including one barrier method during the entire study and for at least 35 days after end of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to show that at least one of the three different chosen concentrations of isotretinoin is non-inferior to doxycycline and superior to placebo. As primary objective the reduction in the total sum of facial papules and pustules/nodudi after a 12 week treatment will be compared between the treatment groups. ;Primary end point(s): The reduction in the total sum of facial papules and pustules/noduli is the primary efficacy variable. The reduction will be measured as difference in the total sum from baseline to end of treatment after 12 weeks. ;Secondary Objective: As secondary objectives the following efficacy variables will be compared between the treatment groups: - changes in the static “Global physician’s assessment score – Rosacea” - changes in the severity scores for erythema, edema, telangiectasia, seborrhoea, and rhinophyma - investigator’s overall improvement rating - patient’s overall improvement rating - changes in the quality of life measured by patient reported outcomes - achievement of patient’s treatment preferences As secondary objectives the following safety variables will be compared between the treatment groups: - changes in laboratory values - overall tolerability based on number and severity of study medication-related AEs/SAEs As a further secondary objectives the following safety variables will be compared between the isotretinoin treatment groups: - changes in the severity scores for mucocutaneous side effects (xerosis cutis, burning and itching, cheilitis, and eye dryness) | — |
Countries
Germany
Outcome results
None listed