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Skin DiseasesmelatransNCT05780606

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

A study testing Exposed to UV in people with Skin Diseases, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for
Skin Diseases
What is being tested?
Exposed to UV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteFrance
Study dates
13 Jun 2024to 11 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 30 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • - 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

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHU de Nice - Hôpital de l'Archet

    Nice, Alpes-maritimes, 06200

Other trials in France

About this study

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.

Conditions
Skin Diseases
Being tested
Exposed to UV
Medical subject headings
Skin Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exposed to UVOther

    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

Study groups in NCT05780606
Study groupRoleWhat they receive
VoluntaryOtherNot described
Receives: Other: Exposed to UV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gene expression

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

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2023
  2. Study start13 Jun 2024
  3. Primary completion11 Jul 2024
  4. Study completion11 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05780606
Sponsor's protocol ID
22-PP-22
Acronym
melatrans
Status last verified
Nov 2024
First submitted
10 Mar 2023
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Exposed to UV in people with Skin Diseases, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gene expression (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.

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