ClinicalTrials.gg
Active, not recruitingNCT06908889Microbiome_SHMUpdated Sep 29, 2026

Characterization of Bacterial and Mycosis Skin Flora in Seborrheic Macular Hypopigmentation - Microbiome

An interventional study of Skin's lesion patients and Skin's lesion vulunteers in Hypopigmentation, sponsored by Centre Hospitalier Universitaire de Nice. Active, not recruiting at 3 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Diagnostic

Updated Sep 29, 2026Now Active, not recruitingPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

Hypopigmented skin changes are commonly encountered by dermatologists. A new dermatological entity was identified as scattered, hypopigmented oval-shaped macules and patches distributed mostly in seborrheic area of the face and of the trunk in dark skinned individuals. This patterned presentation of hypopigmentation was first described in the literature under the name of hypochromic vitiligo or vitiligo minor. Nerveless, histopathological patient's specimens analyzed by Krueger et al. clearly highlight that there is no tangible causal correlation with a diagnosis of vitiligo. They propose to rename this entity to Seborrheic Macular Hypopigmentation (SMH). The etiopathology of this dermatosis is still unknown preventing to propose any satisfactory treatment for this disfiguring affection.The objective of this study is to analyze the bacterial and fungal skin microbiome on hypochromic lesions of SMH compared to the surrounding non-lesional skin of the same patients and to healthy volunteers

02

Conditions studied

  • Hypopigmentation

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03

In context

Hypopigmentation

10 studies on the registry are indexed under Hypopigmentation; 2 are open to participants now.

Browse Hypopigmentation studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 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

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

  1. Female and male patients ≥ 18 years of age
  2. Clinical diagnosis of SMH with lesion of the face
  3. Written obtained before any assessment is performed
  4. Affiliation with a social security scheme
  5. Physical and psychological ability to participate

Exclusion criteria

Exclusion Criteria:

  1. Use of systemic antibiotics or any systemic antifungal treatments within 4 weeks before the inclusion visit
  2. Use of topical antibiotics or any topical antifungal treatments on the face within 2 weeks before the inclusion visit
  3. Use of any topical cream, gel, serum or ointment within 2 days before the inclusion visit
  4. Laser, radiofrequency, peeling or any other procedure on the face in the past 3 months before the inclusion visit
  5. Vulnerable patients: minors, patients under guardianship or curatorship, pregnant or breast-feeding women
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Other
    Patients

    The study population will consist of adult subjects (≥ 18 years) with Seborrheic Macular Hypopigmentation.

    Other: Skin's lesion patients

  • Other
    Vulunteers

    Volunteers will be included once the required number of SMP patients has been attained. Volunteers are going to be recruited only at the coordinator center, the CHU of Nice. Recruitment will be communicated to medical and/or Inserm staff, via an announcement in the respective departments.

    Other: Skin's lesion vulunteers

Interventions

  • OtherSkin's lesion patients

    Skin swabs will be obtained from the patient's facial lesional (FLS) and perilesional sites (FPS) using a sterile cotton swab. The microbiota of the same anatomical face regions will be collected on volunteers, once the 10 SMH patients have been enrolled. The swab is premoistened in a specific cocktail solution and rubbed onto the skin surface for 45sec. The pressure during the sampling involves rubbing the area of interest with a smear over the entire zone. The skin reddens slightly under the exerted pressure.

  • OtherSkin's lesion vulunteers

    Skin swabs will be obtained from the patient's facial lesional (FLS) and perilesional sites (FPS) using a sterile cotton swab. The microbiota of the same anatomical face regions will be collected on volunteers, once the 10 SMH patients have been enrolled. The swab is premoistened in a specific cocktail solution and rubbed onto the skin surface for 45sec. The pressure during the sampling involves rubbing the area of interest with a smear over the entire zone. The skin reddens slightly under the exerted pressure.

06

What researchers measure

Primary outcomes

  1. The bacterial skin microbiome of SMH patients vs voluntheers

    For each sample, the bacterial profiles determined by real time PCR, will be described and compared as follows: seborrheic macular hypopigmented lesions versus same anatomic area in healthy volunteers.

    Time frame: at baseline

Secondary outcomes

  1. The bacterial skin microbiome of SMH patients compare to the non-lesional surrounded skin of the same patients.

    For each sample, the bacterial profiles determined by real time PCR, will be described and compared as follows: intra-individual hypochromic macula lesions versus perilesional areas located at least 1cm away from any hypopigmented macules.

    Time frame: at baseline

07

Study locations

3 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Ran from Jun 2025 to primary completion in Apr 2026, 9 months.

Since we started tracking on Sep 25, 2026, the dates moved once, on Sep 29, 2026: primary completion Jan 2026 → Apr 2026 and completion Jun 2026 → Dec 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2025
First posted
Apr 3, 2025
StartActual
Jun 25, 2025
Primary completionActual
Apr 16, 2026was Jan 2026
CompletionEst.
Dec 25, 2026was Jun 2026
Last update
Sep 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Sep 29, 2026
Primary completion
Jan 25, 2026→Apr 16, 2026 (actual)
Sep 29, 2026
Study completion
Jun 25, 2026→Dec 25, 2026
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Recruiting→Active, not recruiting
    Primary completion Jan 25, 2026→Apr 16, 2026 (now actual)
    Study completion Jun 25, 2026→Dec 25, 2026
    + 4 other changes: verification date, oversight details, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06908889
Responsible party
Sponsor
First posted
Apr 3, 2025
Start date
Jun 25, 2025
Primary completion
Apr 16, 2026
Completion
Dec 25, 2026 (estimated)
Last update
Sep 29, 2026

Study contacts

Thierry Passeron, PhD
principal investigator · CHU de Nice, Service de Dermatologie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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