Microbiome & Psoriasis Study

Phase 1

• Conditions: Psoriasis; MedDRA version: 20.0 Level: LLT Classification code 10050576 Term: Psoriasis vulgaris System Organ Class: 100000004858; Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]

• Registration Number: EUCTR2018-001371-20-FR
• Lead Sponsor: CHU de Nice

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-11
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Patients of both more than 18-year-old sexes having signed and dated a form of information and informed consent.
2. Subject presenting a psoriasis vulgaris with symmetric hurts in size and in severity, located on elbows and\or knees and having a score of severity (PASI)< 10. The hurts will have to have a surface of at least 4 cms ².
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 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

1. Subject presenting a psoriasis in drop(gout), érythrodermique, exfoliatif or pustuleux.
2. Feminine Subject pregnant or breast-feeding.
3. Subject having received a systematic treatment(processing) and having a potential action(share) on the psoriasis vulgaris (ex: phototherapy, cyclosporine, méthotrexate, biotherapics, steroids, or other immunosuppresseurs treatments(processings)) in 2 months preceding the randomization and during all the duration the study.
4. Subject having received a treatment(processing) antibiotic in the previous three months the visit of inclusion
5. Subject having received the topical treatments(processings) (example: corticostéroïdes, tazarotène, analogues of the vitamin D) or neutral emollients in 4 weeks preceding the randomization

Study & Design

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