- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02157688
Impact of Staphylococcus Aureus on Folliculitis Decalvans (SAFE)
Role of Staphylococcus Aureus on Folliculitis Decalvans. A Comparative Bacteriological Study.
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 .
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75010
- Saint-Louis Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
case
Patient with a folliculitis Decalvans
|
|
control
Control without folliculitis decalvans
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
presence of Staphylococcus Aureus in cutaneous biopsies (at least one colony) after treatment
Time Frame: 10 weeks
|
10 weeks
|
presence of Staphylococcus Aureus in nasal swab (at least one colony)
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAFE Folliculitis Decalvans
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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