NCT02251756

Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Study objective To assess the performance of different application regimens of Actinica® on protection from UV rays-induced erythema throughout 1 day of sun exposure in fair-skinned healthy subjects (phototype I to III). Study centers A total of 20 subjects will be enrolled in 1 site in France. Methodology This will be a monocentre, randomised, controlled, investigator-blind, intra-individual comparative clinical investigation. There will be a total of 6 visits for each subject. Each subject will participate for a period of maximum 35 days. Study population Healthy subjects, male or female, at least 18-60 years old, with phototype I, II or III, not pre-treated/pre-protected skin, meeting specific inclusion/exclusion criteria. The clinical investigation will be conducted in 2 parts. Part 1 - SPF determination: To determine the SPF of Actinica® with application of two different amounts (0.8 and 2 mg/cm2). Part 2 - Sun exposure: To assess the performance of the different application regimens of Actinica® on protection from UVR-induced erythema throughout 1 day of sun exposure.

Conditions

• Healthy Subjects, Male or Female, of 18-60 Years Old, With Phototype I, II or III, Not Pre-treated/Pre-protected Skin

Interventions

Type	Name	Description
DEVICE	Actinica, 0.8 mg/cm2, 1 application
DEVICE	Actinica, 0.8 mg/cm2, 2 applications
DEVICE	Actinica, 2 mg/cm2, 1 application
DEVICE	Actinica, 2 mg/cm2, 2 applications

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2014-09-29
• Last updated: 2021-02-18

Locations

1 site across 1 country: France