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

Squamous Cell Carcinomas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04142489
• Other study ID #: 19-AOIP-02
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: July 1, 2021

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 1, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Squamous Cell Carcinomas

Intervention

Other:
• solar irradiation and biopsies
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.

Locations

Country	Name	City	State
France	Nice Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number oh epidermal cells positives	epidermal cells with positive immunolabeling for DNA damage markers (CPD, 6.4PP, p53) count.	6 months