Role of Topical Treatments in the Modulation of Skin Microbiome in Psoriatic Skin

• Status: Completed
• Trial end date: 2019-03-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nice
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Calcipotriene; Calcitriol; Clobetasol

Criteria

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