Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT02251756
Brief 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.
Study:
NCT02251756
Study Brief:
Protocol Section:
NCT02251756