Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06908889

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. The bacterial skin microbiome of SMH patients vs voluntheers

    Time frame: 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 outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Thierry Passeron, PhD

CONTACT

[email protected]

+33492036488

emmanuelle PRADELLI

CONTACT

[email protected]

+33492036488

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: Microbiome_SHM

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.