Double-blind, double-dummy, randomized, placebo-controlled, five-armed, multi-centre phase II/III study to evaluate the efficacy and safety of different concentrations of isotretinoin versus doxycycline in the treatment of rosacea, subtype II and III - AURORA
- Conditions
- 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.
- Registration Number
- EUCTR2006-002410-35-DE
- Lead Sponsor
- Almirall Hermal GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 550
· 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
· 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
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