NCT03136107

Determination of the Sun Protection Factor (SPF) of a Cosmetic Daily De-fence Skin Cream

Determination of the Sun Protection Factor of a Cosmetic Daily Defence Skin Cream

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the SPF of the test product according to the International Standards Organization (ISO) 24444:2010 methodology (In vivo determination of the SPF).

Detailed description

A single-center, randomized, evaluator blind, intra-individual comparison, no treatment and positive controlled clinical study to determine the SPF of Physiogel Daily Defence Protective Day Cream Light as per ISO 24444:2010. The provisional minimal erythemal dose of unprotected skin (MEDu) for each subject will be determined before starting the test phase. Once the provisional MEDu for a subject has been determined, the three test sites will be demarcated. The test product and positive control (P3 reference sunscreen formulation) will be applied to two of the three test sites. The other test site will remain unprotected. All three test sites will be exposed to UV radiation at the expected MED and subsequently evaluated for erythema 16-24 hours after UV exposure.

Conditions

• Sunscreening Agents

Interventions

Type	Name	Description
OTHER	Physiogel Daily Defence Protective Day Cream Light	Investigator controlled, topical application to the epidermis at a dose of 2 milligrams per square centimeter (mg/cm2). Single application.
OTHER	ISO 24444:2010 P3 Standard Sunscreen	Investigator controlled, topical application to the epidermis at a dose of 2 mg/cm2. Single application.

Timeline

• Start date: 2017-05-30
• Primary completion: 2017-06-30
• Completion: 2017-06-30
• First posted: 2017-05-02
• Last updated: 2019-04-19
• Results posted: 2019-04-19

Locations

1 site across 1 country: Germany