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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18-60 years of age, Subject with Phototype I, II or III, Subject with individual typology angle (ITA) 28-70°, Subject with healthy skin / not tanned on the back, Exclusion Criteria: 1. Subject with obvious skin cancer forms within the test areas, 2. Subject with hairs on the treated area that might interfere with clinical investigation assessments, 3. Subjects who have performed sun bathing at least four months before enrolment, 10. History of sun allergy / Mallorca acne, active photo induced or photo aggravated disease, or abnormal response to the sun (e.g., photosensitive dermatoses, polymorphic light eruption, solar urticaria, systemic lupus erythematosus, or dermatomyositis). 11. The subject has received, applied or taken the forbidden treatments within the specified time frame prior to the Day 0 visit (list available on request)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Actinica, 0.8 mg/cm2, 1application<br>Actinica, 0.8 mg/cm2, 1application over one day of sun exposure | Device: Actinica, 0.8 mg/cm2, 1 application<br> <br> |
| Experimental: Actinica, 0.8 mg/cm2, 2 applications<br>Actinica, 0.8 mg/cm2, 2 applications over one day of sun exposure | Device: Actinica, 0.8 mg/cm2, 2 applications<br> <br> |
| Experimental: Actinica, 2 mg/cm2, 1 application<br>Actinica, 2 mg/cm2, 1 application over one day of sun exposure | Device: Actinica, 2 mg/cm2, 1 application<br> <br> |
| Experimental: Actinica, 2 mg/cm2, 2 applications<br>Actinica, 2 mg/cm2, 1 application over one day of sun exposure | Device: Actinica, 2 mg/cm2, 2 applications<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| erythema score |  | Part 2 -Day 1 |