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

NCT06908889 | Recruiting

• 1 other identifier: 24-PP-17
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

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

Conditions

Hypopigmentation

Outcome Measures

Primary Outcomes (1)

• 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.

  at baseline

Secondary Outcomes (1)

• The bacterial skin microbiome of SMH patients compare to the non-lesional surrounded skin of the same patients.

  at baseline

Study Arms (2)

Patients

OTHER

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

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.

Other: Skin's lesion vulunteers

Interventions

Skin's lesion patients 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.

Patients

Skin's lesion vulunteers 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Vulnerable patients: minors, patients under guardianship or curatorship, pregnant or breast-feeding women

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (3)

CHU de Nice - Hôpital de l'Archet

Nice, Alpes-Maritimes, 06200, France

RECRUITING

Hôpital Louis Pasteur, hôpitaux Civils de Colmar

Colmar, Colmar, 68024, France

RECRUITING

Hôpital Saint-Louis - APHP

Paris, Île-de-France Region, 75010, France

RECRUITING

MeSH Terms

Conditions

Hypopigmentation

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Thierry Passeron, PhD

  CHU de Nice, Service de Dermatologie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry Passeron, PhD

CONTACT

+33492036488; passeron.t@chu-nice.fr

emmanuelle PRADELLI

CONTACT

+33492036488; pradelli.e@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 3, 2025
• Study Start: June 25, 2025
• Primary Completion: January 25, 2026
• Study Completion (Estimated): June 25, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)