Psoriasis Vulgaris Clinical Trial
— Microbiome&PsoOfficial title:
Study Role of the Local Treatments on the Microbiome Modulation in the Psoriatic Skin. Study Monocentric, Interventional, Randomized and Single-blind
Verified date | April 2019 |
Source | Centre Hospitalier Universitaire de Nice |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Changes in microbiome have been reported recently in psoriasis lesions compared to healthy surround skin. Preliminary data showed that systemic treatments of psoriasis induce modification of the skin microbiome that becomes similar to healthy individuals after successful treatment. The causative role of microbiome in psoriasis remains in debate. The modification of skin microbiome is suspected to be able to activate the innate immune response, namely natural killers (NKs) and immune lymphoid cells (ILCs). Three types of ILCs have been reported. ILC1 (immune lymphoid cells1) that trigger a Th1 response, ILC2 (immune lymphoid cells 2) that stimulate Th2 response and ILC3 (immune lymphoid cells 3) that induce Th17 response. Interestingly, ILC2 have been reported to be increased in atopic dermatitis while ILC3 are increased in psoriasis.
Status | Completed |
Enrollment | 30 |
Est. completion date | March 7, 2019 |
Est. primary completion date | September 24, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years of age who have signed and dated an informed information and consent form, - Subject presenting psoriasis vulgaris with lesions symmetrical in size and severity, localized on the elbows and the knees and having a severity score (PASI) <=10. The lesions must have an area of at least 4 cm², Exclusion Criteria: - Psoriasis in gout, erythrodermic, exfoliative or pustular - Subject who has received systemic treatment and has a potential action on psoriasis vulgaris - Subject who received topical treatments or neutral emollients within 4 weeks - Subject who received antibiotic treatment in the three months preceding the randomization visit - Subject with known or suspected hypersensitivity to any of the constituents of the products in the study |
Country | Name | City | State |
---|---|---|---|
France | CHU de Nice | Nice |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire de Nice |
France,
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Naldi L, Svensson A, Diepgen T, Elsner P, Grob JJ, Coenraads PJ, Bavinck JN, Williams H; European Dermato-Epidemiology Network. Randomized clinical trials for psoriasis 1977-2000: the EDEN survey. J Invest Dermatol. 2003 May;120(5):738-41. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantitative evaluation of bacterial microbiota on psoriasis lesions and surrounding healthy skin by 16S rRNA (ribosomal ribonucleic acid 16S) amplification coupled with high throughput sequencing | after 4 weeks of treatment | ||
Primary | Qualitative evaluation of bacterial microbiota on psoriasis lesions and surrounding healthy skin by 16S rRNA (ribosomal ribonucleic acid 16S) amplification coupled with high throughput sequencing | after 4 weeks of treatment | ||
Secondary | Targetted Psoriasis Area and Severity Index for the effectiveness of the products tested. | Evaluated by PASI score (PASI= Psoriasis Area Severity Index) minimum = 0 = Absence of psoriasis maximum = 4 = very severe psoriasis | after 4 weeks of treatment | |
Secondary | Number of ILCs and NKs on skin biopsies using immunohistochemistry | after 4 weeks of treatment | ||
Secondary | Types of ILCs and NKs on skin biopsies using immunohistochemistry | after 4 weeks of treatment | ||
Secondary | Score of overall evaluation of the investigator's treatment | Evaluated by physician global assessment (PGA) score PGA = physician global assessment minimum = 0 = healing maximum = 5 = very severe psoriasis | after 4 weeks of treatment | |
Secondary | Evaluation of tolerance | evaluated numbers of serious adverse events | after 4 weeks of treatment | |
Secondary | Occurrence of possible adverse effects | after 4 weeks of treatment |
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