Impact of Staphylococcus Aureus on Folliculitis Decalvans

Staphylococcus Aureus Clinical Trial

— SAFE  

Official title:

Role of Staphylococcus Aureus on Folliculitis Decalvans. A Comparative Bacteriological Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02157688
• Other study ID #: SAFE Folliculitis Decalvans
• Status: Completed
• Phase: N/A
• First received: May 14, 2014
• Last updated: June 23, 2016
• Start date: March 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Ministry of Health
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alopecia
• Folliculitis
• Folliculitis Decalvans
• Staphylococcus Aureus

Intervention

Other:
• no intervention : case control study

Locations

Country	Name	City	State
France	Saint-Louis Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of Staphylococcus Aureus in cutaneous biopsies (at least one colony)	The primary endpoint is the presence of Staphylococcus Aureus in cutaneous biopsies before any therapy and notably antibiotics.	1 day	No
Secondary	presence of Staphylococcus Aureus in cutaneous biopsies (at least one colony) after treatment		10 weeks	No
Secondary	presence of Staphylococcus Aureus in nasal swab (at least one colony)		1 day	No