Efficacy and Safety of IDEA-068 in Plaque Psoriasis - N.A.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

· Informed consent signed and dated
· Chronic stable plaque type psoriasis
· Ohterwise healthy according to physical examination
· Sufficient size and number of psoriatic lesion(s) to select 5 treatment areas and
one untreated control area per plaque*
· Aged >/= 18 years
· Reliable method of contraception (hormonal contraception, condoms, IUD) for
women of childbearing potential
· Willing to abstain from excessive sun / UV exposure (e.g. sunbath, solarium)
during the course of the study

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

· Psoriasis pustulosa or psoriasis erythrodermica or an exanthematic attack of
psoriasis
· Known allergy to pharmaceutical or cosmetic products
· Known hypersensitivity or allergy to corticosteroids
· Systemic treatment with corticosteroids, cytostatics, immunosuppressives,
immunomodulators, immunostimulants and antipsoriatics during the past
4 weeks before baseline line and during the study
· Topical treatment with corticosteroids, tar, cignolin, calcipotriol, topical retinoids
during the past 4 weeks before baseline and during the study
· Application of other topical antipsoriatics in the regions of the test areas, except for
ointments only used for skin care, during the 7 days before treatment
· UV-treatment (UVB, PUVA, SUP, Thermosole-phototherapy and Climatic-therapy)
during the past 4 weeks before baseline
· Clinically relevant abnormal laboratory findings
· Mental disorders
· Drug or alcohol dependency
· Any other chronic or acute illness requiring systemic treatment which might have
any influence on the outcome of the study in the 4 weeks before and during the
study (investigator’s decision).
· Dysplastic naevi or praecancerosis within the area of interest
· Immunodeficiency including HIV
· Pregnancy or lactation
· Participation in another clinical trial within the last 3 days
· Any concomitant medication which might influence the study objectives or are
known to provoke or aggravate psoriasis, e.g. b-blocker, anti-malaria drugs
· Tattoos in the treatment area
· Subjects who are inmates of psychiatric wards, prisons, or other state institutions