Targeted photoprotection of Han Chinese skin: Assessment of skin responses in healthy Chinese versus Caucasians towards UVA1, visible light and visible light plus UVA1 radiation and assessment of the efficacy of two corresponding sunscreen products - A comparative study –

Not Applicable

Recruiting

Conditions: Only healthy subjects

Registration Number: DRKS00034235

Lead Sponsor: IUF - Leibniz-Institut für umweltmed. Forschung GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Age between 20 and 65 years (both inclusive);
- Caucasian and Han Chinese;
- Fitzpatrick skin types III - IV;
- ITA° between 55° and 10°;
- Normal eating habits (3 meals/day); not vegetarian/vegan;
- No known allergy or intolerance to any component of the test preparations; subjects are asked at screening to show an ‘Allergy Pass’ if available;
- Healthy with no clinically significant abnormality identified by medical history and clinical examination, in particular no evidence of abnormal photosensitivity;
- Females capable of becoming pregnant must use contraception and must show a negative urine pregnancy test at V1;
- No use of sun beds for at least three months prior to recruitment into the study and willing to refrain from sun bathing or tanning for the entire duration of the study;
- Must agree not to use dietary supplements (e.g., herbal, vitamin) from the beginning of the study at the screening visit and throughout the study;
- Able to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions;
- Consent to confidential use and storage of all data for scientific purposes, as well as to the use of pseudonymised data for publication;
- Voluntary and active cooperation in the study;
- Agreeing to follow the instructions of the investigator and to attend the centre at the agreed times;
- Handwritten signature of the Informed Consent after the nature of the study has been fully explained.

Exclusion Criteria

- Pregnant or breast-feeding woman;
- Smoker
- Any use of oral nutritional anti-oxidant and/or vitamin supplementation three months before and during the study;
- Use of sunbeds during the last three months or planned vacations for sunbathing during the study;
- Known to have abnormal skin photosensitivity;
- Inflammatory skin disease such as eczema or psoriasis in the designated testing areas;
- Known allergy or intolerance (if possible documented in allergy pass card) to any component of the test preparations or other products administered during the study;
- Immunosuppression due to medications (such as organ transplant recipient) or disease (including HIV or haematological malignancy);
- Medical history of skin cancer including Basal Cell Carcinoma (BCC);
- History of malignancy not curatively treated at least 5 years before screening visit with exception of basal cell or cervical carcinoma in situ which may have been curatively treated within 1 year;
- Any systemic or topical medication, including herbal supplements, within 30 days prior to dosing, apart from paracetamol and systemic contraception;
- Any non-prescribed (excluding paracetamol) systemic or topical medication to the back within seven days of dosing;
- Subjects following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc.;
- Alcohol consumption of more than one unit of hard spirits/day;
- History or current use of illegal or recreational” drugs;
- Individuals diagnosed with communicable diseases (e.g. hepatitis, Covid-19, Mpox)
- Member of high-risk group of hepatitis, HIV, and other infectious diseases;
- Scars, cuts, wounds, intensely tanned skin and dermal abnormalities in the test areas which may influence the result of the study;
- Participation in a clinical research trial within 30 days prior to randomization;
- Unable to understand and comply with protocol requirements and timetables, instructions and protocol-stated restrictions;
- Inability to understand the subject information and comply with the requirements of the protocol and the timetables, instructions and restrictions set out in the protocol due to a language barrier