NCT04250623

Dermatological Assessment of Photoallergy and Phototoxicity

Dermatological Assessment of Photoallergy and Phototoxicity Under Controlled and Maximised Conditions.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Herbarium Laboratorio Botanico Ltda · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a clinical study for health care product safety assessment. The research will be conducted with 40 subjects\*, aged 18 to 70 years. The product will be applied on the right and/or left participant back for 3 consecutive weeks. After 10 days, will have another application of the same product, which will be removed in 24 hours. Medical evaluation will be available throughout the study to assess possible adverse events. The objective of the study is to observe the effects of the application of the product on the skin and prove the absence of photoallergy and phototoxicity. \* 29 completed the trial

Detailed description

40 subjects, aged 18 to 70 years, phototypes II to III (according to Fitzpatrick classification). The patch test will be used to verify the absence of photoallergy and phototoxicity by the investigational products. The products will be applied twice a week for 3 consecutive weeks, as they are over semi-occlusive dressings. The product will remain in contact with the skin for 24 hours, after product removal the area will be irradiated with ultraviolet lamp A and B (UVA/UVB). Then, the procedure will be repeated after 10 days of wash out.

Conditions

• Sensitivity, Contact

Interventions

Type	Name	Description
OTHER	Health care product (gel)	hyaluronic acid intimate moisturizing gel (to be applied on the subject's skin)

Timeline

• Start date: 2021-04-12
• Primary completion: 2021-05-21
• Completion: 2021-05-21
• First posted: 2020-01-31
• Last updated: 2021-06-16

Locations

1 site across 1 country: Brazil