HypopigmentationMicrobiome_SHMNCT06908889
Characterization of Bacterial and Mycosis Skin Flora in Seborrheic Macular Hypopigmentation - Microbiome
A study testing Skin's lesion patients and Skin's lesion vulunteers in people with Hypopigmentation, run by Centre Hospitalier Universitaire de Nice at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypopigmentation
- What is being tested?
- Skin's lesion patients and Skin's lesion vulunteers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesFrance
- Study dates
- 25 Jun 2025to 25 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Female and male patients ≥ 18 years of age
- Clinical diagnosis of SMH with lesion of the face
- Written informed consent obtained before any assessment is performed
- Affiliation with a social security scheme
- Physical and psychological ability to participate
Who cannot join
- Use of systemic antibiotics or any systemic antifungal treatments within 4 weeks before the inclusion visit
- Use of topical antibiotics or any topical antifungal treatments on the face within 2 weeks before the inclusion visit
- Use of any topical cream, gel, serum or ointment within 2 days before the inclusion visit
- Laser, radiofrequency, peeling or any other procedure on the face in the past 3 months before the inclusion visit
- Vulnerable patients: minors, patients under guardianship or curatorship, pregnant or breast-feeding women
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Louis Pasteur, hôpitaux Civils de Colmar
Colmar, Colmar, 68024
CHU de Nice - Hôpital de l'Archet
Nice, Alpes-Maritimes, 06200
Hôpital Saint-Louis - APHP
Paris, Île-de-France Region, 75010
About this study
Official title: Characterization of Bacterial and Mycosis Skin Flora in Seborrheic Macular Hypopigmentation - Microbiome_SHM
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
- Conditions
- Hypopigmentation
- Being tested
- Skin's lesion patients, Skin's lesion vulunteers
- Medical subject headings
- Hypopigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin's lesion patientsOther
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.
Skin's lesion vulunteersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | The study population will consist of adult subjects (≥ 18 years) with Seborrheic Macular Hypopigmentation. Receives: Other: Skin's lesion patients |
| Vulunteers | Other | 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. Receives: Other: Skin's lesion vulunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start25 Jun 2025
- Primary completion16 Apr 2026
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypopigmentationStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study schedule consists of two on-site visit (inclusion and followup). Skin swabs will be obtained from the patient's facial lesional (FLS) and perilesional sites (FPS) located in the same facial area but at least 1 cm away from any hypopigmented macules. One skin swab will be obtained in healthy volunteers matched on sex, age, skin type and location of the skin sample.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thierry Passeron, PhD, Principal investigator, CHU de Nice, Service de Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908889
- Sponsor's protocol ID
- 24-PP-17
- Acronym
- Microbiome_SHM
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Bacterial and Mycosis Skin Flora in Seborrheic Macular Hypopigmentation - Microbiome_SHM
- ClinicalTrials.gov ID
- NCT06908889
- Acronym / sponsor ID
- Microbiome_SHM / 24-PP-17
- Conditions
- Hypopigmentation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 16 Apr 2026 (actual)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 3 Apr 2025 (actual)
- 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.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study schedule consists of two on-site visit (inclusion and followup). Skin swabs will be obtained from the patient's facial lesional (FLS) and perilesional sites (FPS) located in the same facial area but at least 1 cm away from any hypopigmented macules. One skin swab will be obtained in healthy volunteers matched on sex, age, skin type and location of the skin sample.
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Other: Skin's lesion patientsThe study population will consist of adult subjects (≥ 18 years) with Seborrheic Macular Hypopigmentation. |
| Vulunteers | Other | Other: Skin's lesion vulunteersVolunteers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female and male patients ≥ 18 years of age
- Clinical diagnosis of SMH with lesion of the face
- Written informed consent obtained before any assessment is performed
- Affiliation with a social security scheme
- Physical and psychological ability to participate
Key exclusion criteria (5 listed)
- Use of systemic antibiotics or any systemic antifungal treatments within 4 weeks before the inclusion visit
- Use of topical antibiotics or any topical antifungal treatments on the face within 2 weeks before the inclusion visit
- Use of any topical cream, gel, serum or ointment within 2 days before the inclusion visit
- Laser, radiofrequency, peeling or any other procedure on the face in the past 3 months before the inclusion visit
- Vulnerable patients: minors, patients under guardianship or curatorship, pregnant or breast-feeding women
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 |
|---|---|---|
| Skin's lesion patientsSkin 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. | Other | Patients |
| Skin's lesion vulunteersSkin 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. | Other | Vulunteers |
Primary outcome
The bacterial skin microbiome of SMH patients vs voluntheers
Time frame: at baseline
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.
1 secondary outcome
The bacterial skin microbiome of SMH patients compare to the non-lesional surrounded skin of the same patients.
Time frame: at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Thierry Passeron, PhD principal investigator
CHU de Nice, Service de Dermatologie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin's lesion patients and Skin's lesion vulunteers in people with Hypopigmentation, run by Centre Hospitalier Universitaire de Nice at 3 sites 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
The bacterial skin microbiome of SMH patients vs voluntheers (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2026.