Folliculitis DecalvansSAFENCT02157688
Impact of Staphylococcus Aureus on Folliculitis Decalvans
An observational study of Folliculitis Decalvans and Staphylococcus Aureus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Folliculitis Decalvans, Staphylococcus Aureus
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with Folliculitis Decalvans
Who may be able to join
- Adult (>18 yo)
- Alopecia
- folliculitis decalvans
- At least 6 months of evolution
- no antibiotics
- presence of pustules and crusts
- Adult (>18 yo)
Who cannot join
- immunosuppression
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 :
Read more
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 .
- Conditions
- Folliculitis Decalvans, Staphylococcus Aureus
- Being tested
- no intervention : case control study
- Keywords
- folliculitis decalvans, Staphylococcus Aureus, antibiotics
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention : case control studyOther
| Study group | Role | What they receive |
|---|---|---|
| case | Patient with a folliculitis Decalvans Receives: Other: no intervention : case control study | |
| control | Control without folliculitis decalvans Receives: Other: no intervention : case control study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (2)
presence of Staphylococcus Aureus in cutaneous biopsies (at least one colony) after treatment
Measured: 10 weeks
presence of Staphylococcus Aureus in nasal swab (at least one colony)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Folliculitis DecalvansStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02157688
- Sponsor's protocol ID
- SAFE Folliculitis Decalvans
- Acronym
- SAFE
- Status last verified
- Mar 2015
- First submitted
- 14 May 2014
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Staphylococcus Aureus on Folliculitis Decalvans. A Comparative Bacteriological Study.
- ClinicalTrials.gov ID
- NCT02157688
- Acronym / sponsor ID
- SAFE / SAFE Folliculitis Decalvans
- Conditions
- Folliculitis Decalvans, Staphylococcus Aureus
- Keywords
- folliculitis decalvans, Staphylococcus Aureus, antibiotics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Other: no intervention : case control studyPatient with a folliculitis Decalvans |
| control | – | Other: no intervention : case control studyControl without folliculitis decalvans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with Folliculitis Decalvans
Key inclusion criteria (7 listed)
- Adult (>18 yo)
- Alopecia
- folliculitis decalvans
- At least 6 months of evolution
- no antibiotics
Key exclusion criteria (2 listed)
- immunosuppression
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention : case control study | Other | case, control |
Primary outcome
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.
2 secondary outcomes
presence of Staphylococcus Aureus in cutaneous biopsies (at least one colony) after treatment
Time frame: 10 weeks
presence of Staphylococcus Aureus in nasal swab (at least one colony)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2016.
- Derived from this study: PubMed 30907453Matard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Folliculitis Decalvans and Staphylococcus Aureus, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of Staphylococcus Aureus in cutaneous biopsies (at least one colony) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02157688, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2016.