Skin penetration of anti-inflammatory compounds in lesional compared to non-lesional skin of psoriasis patients

Phase 1

• Conditions: Psoriasis vulgaris; MedDRA version: 19.0Level: LLTClassification code 10050576Term: Psoriasis vulgarisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-003802-14-DE
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-14
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 24

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

?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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified