MedPath

/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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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