Healthy volunteers
Conditions
Interventions
7:Apply a product without active ingredients to a 1.5 cm × 1.5 cm area on the buttock expose it to 2 MED (minimal erythemal dose) of ultraviolet light and measure the physicochemical properties of the
2:Apply a product without active ingredients to a 1.5 cm × 1.5 cm area on the buttock expose it to 2 MED (minimal erythemal dose) of ultraviolet light and take a 2 mm tissue biopsy after 8 hours.
6:Apply a product containing active ingredients to a 1.5 cm × 1.5 cm area on the buttock expose it to 2 MED (minimal erythemal dose) of ultraviolet light and measure the physicochemical properties of
4:Apply a product containing active ingredients to a 1.5 cm × 1.5 cm area on the buttock expose it to 1 MED (minimal erythemal dose) of ultraviolet light and measure the physicochemical properties of
3:Leave a 1.5 cm × 1.5 cm area on the buttock untreated (without applying anything) expose it to 2 MED (minimal erythemal dose) of ultraviolet light and take a 2 mm tissue biopsy after 8 hours.
1:Apply a product containing active ingredients to a 1.5 cm × 1.5 cm area on the buttock expose it to 2 MED (minimal erythemal dose) of ultraviolet light and take a 2 mm tissue biopsy after 8 hours.
5:Apply a product without active ingredients to a 1.5 cm × 1.5 cm area on the buttock expose it to 1 MED (minimal erythemal dose) of ultraviolet light and measure the physicochemical properties of the
Sponsors
Shanghai Skin Disease Hospital
Eligibility
Sex/Gender
All
Age
35 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Chinese; 2. Chinese females or males aged 35 to 45 years (inclusive) with corresponding documents to prove their identity; 3. The skin on the lower back (near the waistline) and upper buttocks appears to be of even color visually; 4. Fitzpatrick skin type III; 5. Completed a health history questionnaire in good health and not suffering from any conditions that may interfere with the experiment; 6. Understands the experimental procedures is willing to participate in the experiment and agrees to comply with the experimental requirements; 7. Willing to inform the project physician of any changes in health status during the experiment including colds or the use of various over-the-counter medications; 8. Able to remain still in a prone position for a period of time willing to use patch tests and to apply the test products directly to the buttock skin test sites (the experimental staff may be male or female).
Exclusion criteria
Exclusion criteria: 1. Females who are pregnant (self-reported no clinical verification required) or planning to become pregnant as well as those who are breastfeeding during the course of the experiment. 2. Individuals with a history of phototoxic or photoallergic reactions (such as urticaria rash etc.) or those currently using medications that may cause abnormal reactions to sunlight. 3. Individuals with acute or chronic skin diseases (eczema severe acne psoriasis dermatitis etc.) that the investigator deems may interfere with the assessment of this experiment. 4. Participants who are currently undergoing drug therapy including systemic or topical corticosteroids antibiotics antihistamines immunomodulators aspirin antihypertensive medications. 5. Participants with obvious erythema sunburn tanning uneven skin color cuts abrasions spots moles birthmarks tattoos or excessive hair on the skin of the test area (lower back and upper buttocks). 6. Participants who have intentionally exposed their upper buttocks to ultraviolet light (artificial or natural) during adulthood. 7. The investigator believes that the participant's past or current health status or factors may affect the experimental results. This includes but is not limited to: diabetes cardiovascular diseases (heart disease and hypertension) hepatitis eczema thyroid function (hyperthyroidism or hypothyroidism) psoriasis hypopigmentation. 8. Participants with a history of any type of cancer. 9. Participants who report allergies or sensitivities to cosmetics skincare products moisturizing lotions sunscreens perfumes or any listed ingredients. 10. Participants with a history of skin diseases or other conditions that may affect the experiment. 11. Participants who are currently participating in other clinical studies (including the use of topical local and systemic medications). 12. Participants who have used tanning products in the last 4-6 weeks. 13. Participants who have shaved waxed or used other depilatory products on the test area (lower back and upper buttocks) in the last 1-2 weeks. 14. Participants who report allergies or sensitivities to tape or any adhesives latex alcohol isopropyl alcohol lidocaine. 15. Participants who are using anticoagulant medications such as warfarin coumadin clopidogrel dipyridamole heparin or enoxaparin in the 2 weeks prior to testing and during the experiment. 16. Participants who are using antiplatelet medications such as clopidogrel in the 2 weeks prior to testing and during the experiment. 17. Participants who report a family history including delayed wound healing keloid scarring coagulation disorders or diseases that locally or systemically affect wound healing. 18. Participants who report having coagulation disorders or other conditions that cause excessive bleeding. 19. Participants who report regularly taking prescription and over-the-counter antihistamine medications (such as diphenhydramine cold medicines). Occasional use (no more than 2 times per week) is acceptable. 20. Participants who have taken part in tests related to the lower back or upper buttocks in the past four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical evaluation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Skin color; | — |
Countries
China
Contacts
Public ContactYing Zou
Shanghai Skin Disease Hospital
Outcome results
None listed