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In Vivo Damage Induced bu UV in the Epidermis of the Scalp

Primary Purpose

Squamous Cell Carcinomas

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
solar irradiation and biopsies
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Squamous Cell Carcinomas

Eligibility Criteria

40 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Male subject
  • Subject aged 40 to 60 years
  • Subject of phototype III or IV
  • Subject with no skin lesions on the scalp and forearms
  • Subject who has not been exposed to the sun for at least 1 month
  • Subject affiliated to social security
  • Subject who signed the informed consent form

Exclusion Criteria:

  • Subjects with photosensitivity,
  • Subject taking photosensitizing drugs
  • Subjects with a history of skin cancer
  • Subjects with abnormal healing
  • Subjects with immunosuppression

Sites / Locations

  • Nice Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

UV and biopsy

Arm Description

Minimum erythematous dose (DEM) will be calculated using a solar irradiator on the scalp (study area) and on a forearm (control area). On D2 (D1+24h) a solar irradiation corresponding to 2 DEM will be performed on a region of the scalp (studied area), as well as on a forearm (control area). A 3mm biopsy will be performed 15mn after irradiation in these 2 regions to study DNA damage. At D4 (D2+48h) a 2nd biopsy of 3 mm will be performed to study the repair of induced DNA damage. The study of DNA damage induced by UV will be done by immunohistochemical analysis of markers validated in previous studies: CPD=pyridine dimers, 6.4 PP= "6.4 photoproducts", and p53. Immunolabeling will be performed on skin biopsies collected 15 minutes after UV exposure and 48 hours after UV exposure.

Outcomes

Primary Outcome Measures

number oh epidermal cells positives
epidermal cells with positive immunolabeling for DNA damage markers (CPD, 6.4PP, p53) count.

Secondary Outcome Measures

Full Information

First Posted
October 25, 2019
Last Updated
May 5, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT04142489
Brief Title
In Vivo Damage Induced bu UV in the Epidermis of the Scalp
Official Title
Clinical Study of In Vivo Damage Induced bu UV in the Epidermis of the Scalp
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 10, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

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
Squamous cell carcinomas (SCC) are the second most common skin cancer in humans. The incidence of SCCs in the USA in 2012 was estimated at 700,000 casesSCCs have a metastatic course in 3% to 5% of cases that is of poor prognosis. In men, the SCCs of the scalp represent the most frequent location of the head and neck, the 3rd location of the whole body. The SCCs of the scalp are more undifferentiated than in other locations. In addition, actinic keratoses of scalp, precursors of SCC, are more resistant to treatment than in other areas. These particularities of the SCCs of the scalp suggest the existence of specific factors at the epidermis level of the scalp. UV-induced damage to DNA is the defining event in skin photocarcinogenesis. It has already been shown that DNA damage induced by UV and the kinetics of repair of this damage may vary with age or phototype of patients, but the topographic variation of DNA damage has never been studied, although it is known that gene expression in skin cells may differ from one region of the body to another. the hypothesis is therefore that the particular characteristics of KAs and SCCs at the scal level could be explained by an increased sensitivity to UV-induced damage. It is planned to study UV-induced damage and its repair at the scalp level in humans compared to the forearm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinomas

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
UV and biopsy
Arm Type
Other
Arm Description
Minimum erythematous dose (DEM) will be calculated using a solar irradiator on the scalp (study area) and on a forearm (control area). On D2 (D1+24h) a solar irradiation corresponding to 2 DEM will be performed on a region of the scalp (studied area), as well as on a forearm (control area). A 3mm biopsy will be performed 15mn after irradiation in these 2 regions to study DNA damage. At D4 (D2+48h) a 2nd biopsy of 3 mm will be performed to study the repair of induced DNA damage. The study of DNA damage induced by UV will be done by immunohistochemical analysis of markers validated in previous studies: CPD=pyridine dimers, 6.4 PP= "6.4 photoproducts", and p53. Immunolabeling will be performed on skin biopsies collected 15 minutes after UV exposure and 48 hours after UV exposure.
Intervention Type
Other
Intervention Name(s)
solar irradiation and biopsies
Intervention Description
the minimum erythematous dose (DEM) will be calculated using a solar irradiator on the scalp (study area) and on a forearm (control area). On D2 (D1+24h) a solar irradiation corresponding to 2 DEM will be performed on a region of the scalp (studied area), as well as on a forearm (control area). A 3mm biopsy will be performed 15mn after irradiation in these 2 regions to study DNA damage. At D4 (D2+48h) a 2nd biopsy of 3 mm will be performed to study the repair of induced DNA damage.
Primary Outcome Measure Information:
Title
number oh epidermal cells positives
Description
epidermal cells with positive immunolabeling for DNA damage markers (CPD, 6.4PP, p53) count.
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male subject Subject aged 40 to 60 years Subject of phototype III or IV Subject with no skin lesions on the scalp and forearms Subject who has not been exposed to the sun for at least 1 month Subject affiliated to social security Subject who signed the informed consent form Exclusion Criteria: Subjects with photosensitivity, Subject taking photosensitizing drugs Subjects with a history of skin cancer Subjects with abnormal healing Subjects with immunosuppression
Facility Information:
Facility Name
Nice Hospital
City
Nice
ZIP/Postal Code
06000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

In Vivo Damage Induced bu UV in the Epidermis of the Scalp

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