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OpenTrials
Completed

NCT Number: NCT02157688

Impact of Staphylococcus Aureus on Folliculitis Decalvans

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 .

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Key information

Conditions

Folliculitis Decalvans Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Staphylococcal Infections Staphylococcus Aureus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint-Louis Hospital

Paris, 75010, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no intervention : case control study

Other

Primary outcomes

  1. presence of Staphylococcus Aureus in cutaneous biopsies (at least one colony)

    Time frame: 1 day

    The primary endpoint is the presence of Staphylococcus Aureus in cutaneous biopsies before any therapy and notably antibiotics.

Secondary outcomes

  1. presence of Staphylococcus Aureus in cutaneous biopsies (at least one colony) after treatment

    Time frame: 10 weeks

  2. presence of Staphylococcus Aureus in nasal swab (at least one colony)

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: SAFE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 6, 2014
Registry last updated
Jun 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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