/A
- Conditions
- Patients with mild to moderate plaque psoriasis.MedDRA version: 8.1Level: LLTClassification code 10050576Term: Psoriasis vulgaris
- Registration Number
- EUCTR2006-002523-16-SE
- Lead Sponsor
- Synphora AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Post-menopausal females of Caucasian race, aged below 80 years with mild to moderate chronic plaque psoriasis on arms, legs or trunk diagnosed at least one year prior to baseline visit. Two symmetrical lesions must be separated from each other and within reach of application. Written informed consent obtained at pre-study visit at the latest (before ECG and laboratory tests).
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
Any other relevant skin disorder that may affect the study. Use of systemic psoriasis medications, phototherapy or topical medications on the plaque to be treated with study medication within the past month prior to baseline day (Day 1). (Lesions on the same extremities as those to be treated with study medication should not be treated with local medication during the study. Other lesions may be treated locally with approved psoriatic medication used within the last month prior to Day 1). Emollients may be used up to 1 day before treatment start on the plaque to be treated and throughout the study on all other lesions. Patients with severe allergy and /or severe bronchial asthma. Any clinically relevant laboratory value outside the normal range, or deviating ECG. Hypersensitivity to any of the components in the study drugs. Participation in any other clinical trial within one month prior to Day 1. Alcohol or drug abuse.
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