Skip to content

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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06908889
Acronym
Microbiome_SHM
Enrollment
20
Registered
2025-04-03
Start date
2025-06-25
Completion date
2026-06-25
Last updated
2025-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypopigmentation

Brief 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

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.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frameDescription
The bacterial skin microbiome of SMH patients vs voluntheersat baselineFor 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.

Secondary

MeasureTime frameDescription
The bacterial skin microbiome of SMH patients compare to the non-lesional surrounded skin of the same patients.at baselineFor 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.

Countries

France

Contacts

Primary ContactThierry Passeron, PhD
passeron.t@chu-nice.fr+33492036488
Backup Contactemmanuelle PRADELLI
pradelli.e@chu-nice.fr+33492036488

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026