Status:

COMPLETED

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

Lead Sponsor:

Galderma R&D

Conditions:

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

Eligibility:

All Genders

18-60 years

Phase:

NA

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 (...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

July 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2014

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT02251756

Start Date

July 1 2014

End Date

July 1 2014

Last Update

February 18 2021

Active Locations (1)

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1

Nice, France