Impact of thermo-mechanical intervention on normal ski

Phase 1

• Conditions: Healthy skin on the upper back on 3 participants in study a and 12 participants in study b.; MedDRA version: 20.0Level: SOCClassification code 10022891Term: InvestigationsSystem Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2018-004397-96-DK
• Lead Sponsor: Merete Hædersdal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-29
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

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 with 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified