Psoriasis vulgaris MedDRA version: 19.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858
Conditions
Interventions
Trade Name: Dexamethason 0,05% Creme LAW (CARINOPHARM GmbH
Bahnhofstr. 1831008 Elze, registration number 3000820.00.01)
Product Name: Dexamethason 0,05% Creme LAW
Pharmaceutical Form: Cream
INN or Pr
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: ? Male patients with the clinical diagnosis of psoriasis vul-garis ? age 25-35 years or = 65 years ? Active psoriasis vulgaris lesions of the chronic plaque type, target lesion score = 8, minimum area size in parallel with non-lesional skin (minimum area size 8 cm2) on the one upper thigh ? Skin type Fitzpatrick II-III 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: ? Skin lesions other than psoriasis-plaques in the investiga-tional sites ? Systemic anti-psoriatic therapy with therapies other than biologicals (e.g., retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the trial. ? Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp and/or body psoriasis within the following time period prior to Visit 1 and during the trial: a. etanercept – within 4 weeks prior to Visit 1 b. adalimumab, infliximab – within 2 months prior to Visit 1 c. ustekinumab – within 4 months prior to Visit 1 d. experimental products – within 4 weeks/5 halflives (whichever is longer) prior to Visit 1 ? UVB therapy or excessive sun exposure therapy within 2 weeks prior to Visit 1 or during the trial. ? Any topical treatment on the scalp and body including corticosteroids (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to Visit 1 or during the trial. ? Predisposition to keloid formation or hypertrophic scars ? Known allergies or intolerance against any component of the study products or study material including disinfect-ants, local anesthetics, cyanoacrylate or other glue and tape components ? Known Diabetes mellitus ? Arterial hypertension with values of = 140/90 mmHg at Screening visit ? Medication with beta-blockers ? Known thrombopenia, coagulation disorder or medication with anticoagulant ? Known allergies against any of the substances of the test medication ? Known allergies against local anesthetics ? Known allergy against ingredients of any glues ? Intake of acetylic acid or NSARs 10 days prior to first visit and during the study ? Atopic diseases (atopic dermatitis, allergic rhinitis, allergic asthma) ? History of malignant tumors or systemic immunologic diseases other than psoriasis ? Participation in another clinical trial in the last 4 weeks prior to this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to compare skin barrier physiology, integrity and the penetration of topically applied anti-inflammatory drugs (dexamethasone, tacrolimus) in lesional (chronic psoriasis plaques) and non-lesional skin of young and aged psoriasis patients. ;Secondary Objective: Not applicable;Primary end point(s): 1.Tissue concentrations of topically applied anti-inflammatory drugs (dexamethasone 0,05% or tacrolimus 0,1%, respectively), in lesional (chronic psoriasis plaque) versus non-lesional thigh skin, assessed in eluates obtained by dermal microdialysis and in tissue extracts from skin punch biopsy assessed by mass spectrometry and x-ray microscopy.;Timepoint(s) of evaluation of this end point: Tissue concentration on eluates measured every 30 minutes during 6 hours (total collection time). Tissue concentration of dexamethasone 0,05% and tacrolimus 0,1% 6 hours after topical application will be determined in the skin biopsies using mass spectrometry. eluates, extracts from skin biopsies, non-invasive spectra and spectra from tissue sections. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To assess the skin penetration of topically applied anti-inflammatory compounds (Dexamethason 0,05% Creme LAW®, Protopic® 0,1% Salbe) in lesional compared to non-lesional skin of psoriasis patients. 2. To identify skin barrier parameters in lesional skin compared to non-lesional skin, which could serve as trigger signals for stimuli-responsive drug delivery systems. 3. To compare the penetration and the differences between lesional and non-lesional skin in young patients to those in aged patients. 4. To advance minimal-invasive and non-invasive analytical methods for skin penetration assessment;Timepoint(s) of evaluation of this end point: 1. Skin penetration of dexamethasone 0.05% and tacrolimus 0, 1% will be measured using Raman Microscopy before (Visit 1, and Visit 2 hour 0) and after (Visit 2, hour 6) application of anti-inflammatory compounds. 2. Skin barrier parameters (TEWL, SCH, pH, OCT, confocal microscopy) will be measured on visit 1 for lesional and non-lesional skin areas. 3. Penetration profiles before (Visit 1, and Visit 2 hour 0) and after (Visit 2, hour 6) application of dexamethasone 0,05% or tacrolismus 0,1% will be compared between young and aged patients. 4. The minimal invasive microdialysis will be performed on Visit 2 for a total period of 6 hours; the non-invasive procedure cyanoacrylate skin surface stripping will be perfomed at visit 1 to acess protease activity of lesional and non-lesional skin. | — |
Countries
Germany
Contacts
Public ContactCharité -Universitätsmedizin Berlin
Charité -Universitätsmedizin Berlin
Outcome results
None listed