chronic stable plaque type psoriasis
Conditions
Interventions
Product Name: IDEA-068
Product Code: IDEA-068/10
Pharmaceutical Form: Cutaneous suspension
INN or Proposed INN: clobetasol
CAS Number: 25122-46-7
Current Sponsor code: IDEA-068/10
Other descriptive na
Sponsors
Idea AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy of IDEA-068 D1 (highest dose) compared to Dermoxinale® To determine the safety of IDEA-068 D1 (highest dose) defined by skin atrophy compared to Dermoxinale® ;Secondary Objective: To determine the minimal effective dose of IDEA-068 in the treatment of plaque psoriasis compared to placebo;Primary end point(s): efficacy assessment: mean change in local PASI-score after 3 weeks of treatment safety assessment: mean change in skin atrophy after 3 weeks of treatment The study objectives are to show that treatment with IDEA-068 D1 (highest dose) is not inferior to treatment with Dermoxinale® concerning the efficacy and to show that treatment with IDEA-068 D1 (highest dose) is superior to treatment with Dermoxinale® concerning safety measured as skin atrophy. | — |
Countries
Germany
Outcome results
None listed