TMFI Enhances Skin Surface and Epidermal PpIX Fluorescence

• Status: Completed
• Trial end date: 2019-12-09
• Target enrollment: 0
• Participant gender: All

Summary

This study investigates a relatively new device TMFI and incubation of ALA in a cream-vehicle and a gel-vehicle.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Merete Haedersdal
• Treatments: Aminolevulinic Acid; Protoporphyrin IX

Criteria

Inclusion Criteria: Healthy participants above 18 years of age

• Fitzpatrick skin type I-III and normal skin on the upper back

• Fertile women with negative U-hCG and use of safe anticontraceptive during the entire study period e.g. oral hormonal contraceptives, intrauterine devices, subdermal implantation or hormonal vaginal ring

• Provided informed written consent

Exclusion Criteria:

• No previous PDT or laser treatment within the past 6 months in the study areas

• Pregnant or lactating women

• Participants with known allergy to 5-ALA, lidocaine or any excipients to components in the vehicles

• Considered unable to follow the study protocol