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

NCT03584360 | Completed Phase 2

• 1 other identifier: 18-PP-03
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Targetted Psoriasis Area and Severity Index for the effectiveness of the products tested.

  after 4 weeks of treatment

• Number of ILCs and NKs on skin biopsies using immunohistochemistry

  after 4 weeks of treatment

• Types of ILCs and NKs on skin biopsies using immunohistochemistry

  after 4 weeks of treatment

• Score of overall evaluation of the investigator's treatment

  after 4 weeks of treatment

• Evaluation of tolerance

  after 4 weeks of treatment

Study Arms (3)

betamethasone-calcipotriol versus placebo

EXPERIMENTAL

In this arm we will compared the application association of betamethasone-calcipotriol foam in an area versus a placebo foam in an other area during 4 weeks.

Drug: Betamethasone-Calcipotriene Topical

betamethasone-calcipotriol versus betamethasone

EXPERIMENTAL

In this arm we will compared the application association of betamethasone-calcipotriol foam in an area versus a betamethasone pomade in an other area during 4 weeks.

Drug: Betamethasone-Calcipotriene Topical

betamethasone-calcipotriol versus propionate of clobetasol

EXPERIMENTAL

In this arm we will compared the application association of betamethasone-calcipotriol foam in an area versus a propionate of clobetasol pomade in an other area during 4 weeks.

Drug: Betamethasone-Calcipotriene Topical

Interventions

Betamethasone-Calcipotriene Topical DRUG

Comparison between betamethasone-calcipotriol and placebo

betamethasone-calcipotriol versus placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

Related Publications (7)

• Javitz HS, Ward MM, Farber E, Nail L, Vallow SG. The direct cost of care for psoriasis and psoriatic arthritis in the United States. J Am Acad Dermatol. 2002 Jun;46(6):850-60. doi: 10.1067/mjd.2002.119669.

  PMID: 12063481 BACKGROUND

• Schmitt JM, Ford DE. Work limitations and productivity loss are associated with health-related quality of life but not with clinical severity in patients with psoriasis. Dermatology. 2006;213(2):102-10. doi: 10.1159/000093848.

  PMID: 16902286 BACKGROUND

• Wong VW, Martindale RG, Longaker MT, Gurtner GC. From germ theory to germ therapy: skin microbiota, chronic wounds, and probiotics. Plast Reconstr Surg. 2013 Nov;132(5):854e-861e. doi: 10.1097/PRS.0b013e3182a3c11e.

  PMID: 24165637 BACKGROUND

• Mathieu A, Vogel TM, Simonet P. The future of skin metagenomics. Res Microbiol. 2014 Feb-Mar;165(2):69-76. doi: 10.1016/j.resmic.2013.12.002. Epub 2013 Dec 20.

  PMID: 24361423 BACKGROUND

• Kong HH, Andersson B, Clavel T, Common JE, Jackson SA, Olson ND, Segre JA, Traidl-Hoffmann C. Performing Skin Microbiome Research: A Method to the Madness. J Invest Dermatol. 2017 Mar;137(3):561-568. doi: 10.1016/j.jid.2016.10.033. Epub 2017 Jan 4.

  PMID: 28063650 BACKGROUND

• Kong HH, Segre JA. The Molecular Revolution in Cutaneous Biology: Investigating the Skin Microbiome. J Invest Dermatol. 2017 May;137(5):e119-e122. doi: 10.1016/j.jid.2016.07.045.

  PMID: 28411842 BACKGROUND

• 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. doi: 10.1046/j.1523-1747.2003.12145.x.

  PMID: 12713574 RESULT

MeSH Terms

Interventions

betamethasone dipropionate, calcipotriol drug combination

Study Officials

• Thierry PASSERON, MD, PhD

  university hospital center of nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The patient will not say the treatment he puts on each treatment area
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patients apply different treatment to two areas with psoriasis

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 12, 2018
• Study Start: September 24, 2018
• Primary Completion: September 24, 2018
• Study Completion: March 7, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)