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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
erythema score	Part 2 -Day 1

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimate): September 29, 2014

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations; Erythema
• Other Study ID Numbers: RD.03.CIP.29114; ID RCB: 2014-A00491-46 (Other Identifier: French Health Authority (ANSM))