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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02251756

Enrollment

Registered

2014-09-29

Start date

2014-07-31

Completion date

2014-07-31

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEActinica, 0.8 mg/cm2, 1 application

DEVICEActinica, 0.8 mg/cm2, 2 applications

DEVICEActinica, 2 mg/cm2, 1 application

DEVICEActinica, 2 mg/cm2, 2 applications

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
erythema score	Part 2 -Day 1

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026