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CompletedNCT02157688SAFEUpdated Jun 24, 2016

Impact of Staphylococcus Aureus on Folliculitis Decalvans

An observational study in Folliculitis Decalvans and Staphylococcus Aureus, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-24.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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 .

02

Conditions studied

  • Folliculitis Decalvans
  • Staphylococcus Aureus

Keywords

  • folliculitis decalvans
  • Staphylococcus Aureus
  • antibiotics
03

In context

Staphylococcal Infections

278 studies on the registry are indexed under Staphylococcal Infections; 29 are open to participants now.

This study's enrollment of 40 is below the median of 198 across 82 observational studies indexed under Staphylococcal Infections.

Browse Staphylococcal Infections studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adult patients with Folliculitis Decalvans

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • immunosuppression
  • pregnancy
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • case

    Patient with a folliculitis Decalvans

    Other: no intervention : case control study

  • control

    Control without folliculitis decalvans

    Other: no intervention : case control study

Interventions

  • Otherno intervention : case control study
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

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

07

Study locations

1 site
  • Saint-Louis Hospital
    Paris, Paris 75010, France
08

References and documents

Publications

  • Matard B, Donay JL, Resche-Rigon M, Tristan A, Farhi D, Rousseau C, Mercier-Delarue S, Cavelier-Balloy B, Assouly P, Petit A, Bagot M, Reygagne P. Folliculitis decalvans is characterized by a persistent, abnormal subepidermal microbiota. Exp Dermatol. 2020 Mar;29(3):295-298. doi: 10.1111/exd.13916. Epub 2019 May 15. PubMed 30907453 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02157688
Responsible party
Sponsor
First posted
Jun 6, 2014
Start date
Mar 2014
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Jun 24, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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