Clinical trial NCT06908889: Characterization of Bacterial and Mycosis Skin Flora in Seborrheic Macular Hypopigmentation - Microbiome
Official title: Characterization of Bacterial and Mycosis Skin Flora in Seborrheic Macular Hypopigmentation - Microbiome_SHM
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hypopigmentation
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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


Eligibility criteria: 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

Primary outcomes:
measure: The bacterial skin microbiome of SMH patients vs voluntheers
timeFrame: at baseline
Secondary outcomes:
measure: The bacterial skin microbiome of SMH patients compare to the non-lesional surrounded skin of the same patients.
timeFrame: at baseline
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Hôpital de l'Archet
state: Alpes-Maritimes
city: Paris
country: France
facility: Hôpital Saint-Louis - APHP
state: Ile De France
city: Colmar
country: France
facility: Hôpital Louis Pasteur, hôpitaux Civils de Colmar
Study officials:
affiliation: CHU de Nice, Service de Dermatologie
name: Thierry Passeron, PhD
role: PRINCIPAL_INVESTIGATOR
References: