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Trial record 3 of 15 for:    "Folliculitis"

Impact of Staphylococcus Aureus on Folliculitis Decalvans (SAFE)

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ClinicalTrials.gov Identifier: NCT02157688
Recruitment Status : Completed
First Posted : June 6, 2014
Last Update Posted : June 24, 2016
Sponsor:
Information provided by (Responsible Party):
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 .


Condition or disease Intervention/treatment
Folliculitis Decalvans Staphylococcus Aureus Other: no intervention : case control study

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Role of Staphylococcus Aureus on Folliculitis Decalvans. A Comparative Bacteriological Study.
Study Start Date : March 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015


Group/Cohort Intervention/treatment
case
Patient with a folliculitis Decalvans
Other: no intervention : case control study
control
Control without folliculitis decalvans
Other: no intervention : case control study



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with Folliculitis Decalvans
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02157688


Locations
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France
Saint-Louis Hospital
Paris, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02157688     History of Changes
Other Study ID Numbers: SAFE Folliculitis Decalvans
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: June 24, 2016
Last Verified: March 2015
Keywords provided by Assistance Publique - Hôpitaux de Paris:
folliculitis decalvans
Staphylococcus Aureus
antibiotics
Additional relevant MeSH terms:
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Folliculitis
Alopecia
Hair Diseases
Skin Diseases
Hypotrichosis
Pathological Conditions, Anatomical