Characterization of Bacterial and Mycosis Skin Flora in Seborrheic Macular Hypopigmentation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-25

Study Completion Date

2026-06-25

Brief Summary

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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

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Detailed Description

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Conditions

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Hypopigmentation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients

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

Group Type OTHER

Skin's lesion patients

Intervention Type OTHER

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.

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.

Group Type OTHER

Skin's lesion vulunteers

Intervention Type OTHER

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.

Interventions

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Skin'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.

Intervention Type OTHER

Skin'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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes