A Double-Blind, Randomised, Placebo-Controlled Study to Evaluate the Photoprotective Effect of a Sustained Release dose of Melanotan in Fair skinned Healthy Caucasians
Phase 2
Completed
- Conditions
- SunburnSkin - Normal skin development and function
- Registration Number
- ACTRN12605000370606
- Lead Sponsor
- Epitan Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Healthy Caucasian men and women.
Exclusion Criteria
History of skin cancer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare erythemal response 24hr post solar-stimulated irradiation in Melanotan-treated and placebo-treated individuals[At 4, 8 and 12 weeks after initiation of dosing]
- Secondary Outcome Measures
Name Time Method To compare the incidence of DNA damage (thymine dimers) elicited 30 minutes after controlled solar irradiation (3x MED) to a small area of buttock skin (1 x 1 cm).[At baseline and 8 weeks after initiation of dosing with Melanotan or placebo.]