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OpenTrials
Completed

NCT Number: NCT02251756

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 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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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nice, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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).
  • 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)

Treatment and study plan

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

Device

Primary outcomes

  1. erythema score

    Time frame: Part 2 -Day 1

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Sep 29, 2014
Registry last updated
Feb 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.