healthy subjects
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Over 18 years of age, no known skin diseases, skin type of I-IV (Fitzpatrick), informed about the aims of the study and the nature of the examinations, written informed consent to participate, no intensive sun exposure on the skin areas to be irradiated on the lower back/hip within the last 14 days prior to the irradiation date.
Exclusion criteria
Exclusion criteria: Minors, nursing mothers and women with known pregnancy, known skin diseases, skin type >IV (Fitzpatrick), intensive sun exposure on the skin areas to be irradiated on the lower back/hip within the last 14 days before the irradiation date, persons who cannot make decisions on their own responsibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin damage after Far UVC irradiation of 60 mJ/cm² 233 nm is equal to or less than ¼ MED UVB irradiation 24 h after irradiation. For this purpose, 3 mm biopsies are taken 24 h after irradiation and examined immunohistologically for DNA damage. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint 1: Skin damage after Far-UVC irradiation of 60 mJ/cm² 233 nm is lower 24 h after irradiation in dark skin than in light skin. For this purpose, 3 mm biopsies are taken 24 h after irradiation and examined immunohistologically for DNA damage. Secondary endpoint 2: Skin damage after Far-UVC irradiation of 60 mJ/cm² 233 nm increases proportionally with increasing age of the subjects 24 h after irradiation. For this purpose, 3 mm biopsies are taken 24 h after irradiation and examined immunohistologically for DNA damage. Secondary endpoint 3: The carotenoid content of the skin after Far-UVC irradiation of 60 mJ/cm² 233 nm is unchanged 24 h after irradiation. For this purpose, a non-invasive optical measurement by resonance Raman spectroscopy is performed on the irradiated skin areas 24 h after irradiation. Secondary endpoint 4: After 4 times of Far-UVC irradiation of 60 mJ/cm² 233 nm at intervals of 24 h each, no more DNA damage is observed 24 h after the last irradiation than in unirradiated skin. For this purpose, 3 mm biopsies are taken 24 h after the last irradiation and examined immunohistologically for DNA damage. | — |
Countries
Germany
Contacts
Charité – Universitätsmedizin Berlin,Department of Dermatology, Venerology and Allergology,Center of Experimental and Applied Cutaneous Physiology (CCP)