Impact of Staphylococcus Aureus on Folliculitis Decalvans

Completed

• Conditions: Folliculitis Decalvans; Staphylococcus Aureus

• Registration Number: NCT02157688
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The folliculitis decalvans (FD) is an orphan disease , common in consultation specialized on scalp. This disease is currently not curable, responsible for significant for patients. The pathophysiology is poorly understood, Staphylococcus aureus (SA) appears to play a role, never previously studied, and the study will attempt to clarify it.

Controversies in the literature on the pathophysiological hypotheses can be summed up as follows :

FD is it an infectious folliculitis where SA (almost always found on the lesions plays a direct role possibly aided by a lack of local immune protection , or is it a pustular inflammatory unknown cause where the SA has no direct role but is a cofactor or a simple germ superinfection.

Our study has plans to bring new evidence to help decide between these two opposite but not mutually exclusive concepts .

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-06-04
• Study First Posted: 2014-06-06
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2016-06-23
• Last Update Posted: 2016-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Adult (>18 yo)
• Alopecia
• folliculitis decalvans
• At least 6 months of evolution
• no antibiotics
• presence of pustules and crusts
• Adult (>18 yo)

Exclusion Criteria

• immunosuppression
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
presence of Staphylococcus Aureus in cutaneous biopsies (at least one colony)	1 day	The primary endpoint is the presence of Staphylococcus Aureus in cutaneous biopsies before any therapy and notably antibiotics.

Secondary Outcome Measures

Name	Time	Method
presence of Staphylococcus Aureus in cutaneous biopsies (at least one colony) after treatment	10 weeks
presence of Staphylococcus Aureus in nasal swab (at least one colony)	1 day

Trial Locations

Locations (1)

Saint-Louis Hospital; 🇫🇷 Paris, France