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Single-cell Transcriptome Identification of UV- and Visible-light-induced Genes in Human Melanocytes in Vivo (melatrans)

Primary Purpose

Skin Diseases

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Exposed to UV
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Skin Diseases

Eligibility Criteria

20 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Subjects of male sex, phototype III (on the Fitzpatrick scale from I to VI), age 25+5 years and of similar build (body mass index between 20 and 28). - Subject not having been exposed to natural or artificial sunlight in the regions studied for at least 3 months, and not presenting a tan at this level. - Subject showing no skin pathology, scar, or tattoo, in the regions studied. - Subjects who agreed to have a blood test with HIV, hepatitis B and C testing. - Subjects affiliated to a social security scheme - Subjects informed of the aims and nature of the test and having signed a written consent before the start of the study. - Subjects having undergone a general clinical examination attesting to their ability to participate in the study. Exclusion Criteria: - Subjects with a history of dystrophic scarring, particularly of keloids. The preliminary medical examination will endeavor to examine the possible scars of the subject. - Subjects with a dermatological condition that may interfere with assessments. - Subjects with a history of skin cancer. - Subjects having had recourse during the fifteen days preceding the test to systemic or local therapies that risk interfering with the results of the study (eg: corticosteroids, anti-histamines, non-steroidal anti-inflammatory drugs). - Subjects with positive HIV, Hepatitis B (HBSAg surface antigen) and Hepatitis C antibody tests, therefore accepting a blood sample for HIV, hepatitis B and C testing. - Subjects with a history of illness likely, according to the investigator, to put them at risk as a result of the study, in particular photodermatosis, photoaggravated pathologies, atopic dermatitis, chronic urticaria, actinic keratoses, etc. - Subjects allergic to xylocaine adrenaline - Subjects who regularly use sedatives, tranquilizers or other medications known to be photosensitizers - Subjects who have already participated in a pharmacological

Sites / Locations

  • CHU de Nice - Hôpital de l'ArchetRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Voluntary

Arm Description

Outcomes

Primary Outcome Measures

Gene expression
Describe the variations in gene expression induced by solar ultraviolet (UV) radiation or blue light in human melanocytes in vivo

Secondary Outcome Measures

Full Information

First Posted
March 10, 2023
Last Updated
September 5, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT05780606
Brief Title
Single-cell Transcriptome Identification of UV- and Visible-light-induced Genes in Human Melanocytes in Vivo
Acronym
melatrans
Official Title
Single-cell Transcriptome Identification of UV- and Visible-light-induced Genes in Human Melanocytes in Vivo
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Medical condition and pathology studied skin pigmentation. Justification / rationale for the study UV are both the physiological stimulus for skin pigmentation and the main etiological factor in melanoma. Recently, visible (blue) light has also been described to induce skin pigmentation, without any obvious pro-carcinogenic effect. Studies have been carried out to identify genes induced by UV in melanocytes and to understand the mechanisms responsible for photo-induced skin pigmentation. However, the rarity of these cells in the epidermis (3% of cells) has so far been an insurmountable obstacle to achieving this goal. The same is true for visible light, for which the data is even more patchy. The advent of transcriptome analysis techniques at the single cell or single nucleus level will allow us to overcome this obstacle and identify the transcriptional effects of UV and blue light in melanocytes in-situ, as well as in other skin cells (keratinocytes, fibroblasts). Understanding the molecular mechanisms regulated by UV and blue light in melanocytes and other cells will reveal new key steps in skin pigmentation. The data from our study will be used to develop new photoprotective agents as well as new treatments for pigmentary pathologies. Primary objective Describe the variations in gene expression induced by solar ultraviolet (UV) radiation or blue light in human melanocytes in vivo. Secondary objectives Describe the variations in gene expression induced by ultraviolet (UV) radiation sunlight or blue light in other skin cells. Evaluation criteria Single cell transcriptome analysis Immunolabelling on skin sections Population and number of inclusions Healthy male volunteers, phototype III on the Fitzpatrick scale, age 25 + 5 years and of similar corpulence (body mass index between 20 and 28). 2 inclusions Duration of the study Total duration of the study: 12 months Duration of the inclusion phase: 1 month Duration of participation for a patient: 11 days Methodology Two healthy volunteers will be exposed to UV or visible light in the forearm region. Suction blisters, and skin biopsies will be performed in the test areas, suction bubbles for transcriptome, biopsies for immunohistochemistry. The study of gene expression in the different cell types will be done by RNA-Seq on single cells, using the 10X genomics approach. Finally a validation of the results will be carried out by immunostaining with specific antibodies or RNA-Scope. Course of the study - Day 1: The study begins with the determination of the Minimum Erythemal Dose (MED) for each subject in the region of the forearms. This determination will be carried out by means of the administration of six different doses in increasing stages of 25% of UVB + UVA rays (simulated solar ultraviolet spectrum) on six selected test areas (each 1.3 cm²). Exposed areas will be assessed 24 + 2 hours after exposure on Day 2, erythema will be assessed Day 2: Reading of the DEM, and irradiations on two zones in the region of the forearms with respectively a dose of 2 DEM UV, and 48J/cm2 in visible light. A third non-irradiated area will serve as a control. Day 3: A skin blister and biopsy will be performed on each of the three test areas. Cells collected in the blister fluid will be used for the transcriptome and biopsies for validation by immunohistochemistry. Day 11: The subjects will be seen again eight days after the day of sampling, i.e. on Day 11 for removal of sutures and monitoring of healing. On the same day, an evaluation of the level of UV pigmentation induced on each test area will be carried out visually and by colorimetry.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Diseases

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Voluntary
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Exposed to UV
Intervention Description
Two healthy volunteers will be exposed to UV or visible light in the forearm region. Suction bubbles, and skin biopsies will be performed in test areas, suction bubbles for transcriptome, biopsies for immunohistochemistry
Primary Outcome Measure Information:
Title
Gene expression
Description
Describe the variations in gene expression induced by solar ultraviolet (UV) radiation or blue light in human melanocytes in vivo
Time Frame
24 hours

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects of male sex, phototype III (on the Fitzpatrick scale from I to VI), age 25+5 years and of similar build (body mass index between 20 and 28). - Subject not having been exposed to natural or artificial sunlight in the regions studied for at least 3 months, and not presenting a tan at this level. - Subject showing no skin pathology, scar, or tattoo, in the regions studied. - Subjects who agreed to have a blood test with HIV, hepatitis B and C testing. - Subjects affiliated to a social security scheme - Subjects informed of the aims and nature of the test and having signed a written consent before the start of the study. - Subjects having undergone a general clinical examination attesting to their ability to participate in the study. Exclusion Criteria: - Subjects with a history of dystrophic scarring, particularly of keloids. The preliminary medical examination will endeavor to examine the possible scars of the subject. - Subjects with a dermatological condition that may interfere with assessments. - Subjects with a history of skin cancer. - Subjects having had recourse during the fifteen days preceding the test to systemic or local therapies that risk interfering with the results of the study (eg: corticosteroids, anti-histamines, non-steroidal anti-inflammatory drugs). - Subjects with positive HIV, Hepatitis B (HBSAg surface antigen) and Hepatitis C antibody tests, therefore accepting a blood sample for HIV, hepatitis B and C testing. - Subjects with a history of illness likely, according to the investigator, to put them at risk as a result of the study, in particular photodermatosis, photoaggravated pathologies, atopic dermatitis, chronic urticaria, actinic keratoses, etc. - Subjects allergic to xylocaine adrenaline - Subjects who regularly use sedatives, tranquilizers or other medications known to be photosensitizers - Subjects who have already participated in a pharmacological
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bahadoran Philippe, PhD
Phone
0033492036484
Email
bahadoran.p@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bahadoran Philippe, PhD
Organizational Affiliation
CHU de Nice, Service de Dermatologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice - Hôpital de l'Archet
City
Nice
State/Province
Alpes-maritimes
ZIP/Postal Code
06200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bahadoran Philippe, PhD
Email
bahadoran.p@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Bahadoran Philippe

12. IPD Sharing Statement

Learn more about this trial

Single-cell Transcriptome Identification of UV- and Visible-light-induced Genes in Human Melanocytes in Vivo

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