Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-01-04 @ 9:29 PM
Study NCT ID:
NCT02251756
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2014-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance of Different Application Regimens of ACTINICA® on Protection From UVR-induced Erythema After One Day of Sun Exposure in Fair-skinned Healthy Subjects.
Sponsor:
Galderma R&D
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2014-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ID RCB: 2014-A00491-46 | OTHER | French Health Authority (ANSM) | View |