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

Not Applicable

Recruiting

• Conditions: Hypopigmentation

• Registration Number: NCT06908889
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-04-01
• Study First Posted: 2025-04-03
• Status Verified: 2025-06
• Study Start: 2025-06-25
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-07-01
• Primary Completion: 2026-01-25
• Study Completion: 2026-06-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The bacterial skin microbiome of SMH patients vs voluntheers	at baseline	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.

Secondary Outcome Measures

Name	Time	Method
The bacterial skin microbiome of SMH patients compare to the non-lesional surrounded skin of the same patients.	at baseline	For 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.

Trial Locations

Locations (3)

CHU de Nice - Hôpital de l'Archet; 🇫🇷 Nice, Alpes-Maritimes, France

Hôpital Saint-Louis - APHP; 🇫🇷 Paris, Ile de France, France

Hôpital Louis Pasteur, hôpitaux Civils de Colmar; 🇫🇷 Colmar, France