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

C

Centre Hospitalier Universitaire de Nice

Status

Enrolling

Conditions

Hypopigmentation

Treatments

Other: Skin's lesion patients
Other: Skin's lesion vulunteers

Study type

Interventional

Funder types

Other

Identifiers

NCT06908889
24-PP-17

Details and patient eligibility

About

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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Patients
Other group
Description:
The study population will consist of adult subjects (≥ 18 years) with Seborrheic Macular Hypopigmentation.
Treatment:
Other: Skin's lesion patients
Vulunteers
Other group
Description:
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.
Treatment:
Other: Skin's lesion vulunteers

Trial contacts and locations

3

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Central trial contact

emmanuelle PRADELLI; Thierry Passeron, PhD

Data sourced from clinicaltrials.gov

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