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

Overview

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

• Other 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 e
• 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 e

Primary outcome measures

• The bacterial skin microbiome of SMH patients vs voluntheers [Time frame: at baseline]

Secondary outcome measures (1)

• The bacterial skin microbiome of SMH patients compare to the non-lesional surrounded skin of the same patients. [Time frame: at baseline]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

France · 3 centers

• CHU de Nice - Hôpital de l'Archet — Nice
• Hôpital Louis Pasteur, hôpitaux Civils de Colmar — Colmar
• Hôpital Saint-Louis - APHP — Paris

Identifiers

NCT: NCT06908889 · 24-PP-17

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗