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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-07-31

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.

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Detailed Description

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Actinica, 0.8 mg/cm2, 1application

Actinica, 0.8 mg/cm2, 1application over one day of sun exposure

Group Type EXPERIMENTAL

Actinica, 0.8 mg/cm2, 1 application

Intervention Type DEVICE

Actinica, 0.8 mg/cm2, 2 applications

Actinica, 0.8 mg/cm2, 2 applications over one day of sun exposure

Group Type EXPERIMENTAL

Actinica, 0.8 mg/cm2, 2 applications

Intervention Type DEVICE

Actinica, 2 mg/cm2, 1 application

Actinica, 2 mg/cm2, 1 application over one day of sun exposure

Group Type EXPERIMENTAL

Actinica, 2 mg/cm2, 1 application

Intervention Type DEVICE

Actinica, 2 mg/cm2, 2 applications

Actinica, 2 mg/cm2, 1 application over one day of sun exposure

Group Type EXPERIMENTAL

Actinica, 2 mg/cm2, 2 applications

Intervention Type DEVICE

Interventions

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Actinica, 0.8 mg/cm2, 1 application

Intervention Type DEVICE

Actinica, 0.8 mg/cm2, 2 applications

Intervention Type DEVICE

Actinica, 2 mg/cm2, 1 application

Intervention Type DEVICE

Actinica, 2 mg/cm2, 2 applications

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or female, 18-60 years of age,
2. Subject with Phototype I, II or III,
3. Subject with individual typology angle (ITA) 28-70°,
4. 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes