NCT03157583

A Study to Measure the Sun Protection Factor (SPF) and Ultraviolet-A Protection Factor (UVAPF) of Four Developmental Sunscreen Formulations

Determination of the Sun Protection Factor (SPF) and in Vitro UVA Protection Factor (UVAPF) of Four Developmental Sunscreen Formulations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (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 and UVAPF of four sunscreen formulations using international standard methodologies ISO24444:2010 for SPF and ISO24443:2012 for UVAPF.

Detailed description

This study consist of two steps. Step 1: determination of the SPF of the test products which will be performed as a single-center, randomized, evaluator blind, intra-individual comparison, no treatment and positive controlled clinical study as per ISO24444:2010. And Step 2: determination of the UVAPF of the test products which will be performed as a single center, open-label, negative and positive controlled technical test as per ISO24443:2012 (using test plates for assessing UV transmittance of four developmental sunscreens).

Conditions

• Sunscreening Agents

Interventions

Type	Name	Description
OTHER	NGBUV000A, (Expected SPF 30)	A total of 2.0 ± 0.05 mg/cm2 (milligram per centimeter square of test site area) NGBUV000A (test product 1) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 1 will be applied to the test plates.
OTHER	NGBUV000B, (Expected SPF 30)	A total of 2.0 ± 0.05 mg/cm2 NGBUV000B (test product 2) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 2 will be applied to the test plates.
OTHER	NGBUV000C, (Expected SPF 30)	A total of 2.0 ± 0.05 mg/cm2 NGBUV000C (test product 3) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 3 will be applied to the test plates.
OTHER	NGBUV000D, (Expected SPF 30)	A total of 2.0 ± 0.05 mg/cm2 NGBUV000D (test product 4) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 4 will be applied to the test plates.
OTHER	P3 Standard, (Expected SPF 16)	A total of 2.0 ± 0.05 mg/cm2 reference P3 standard will be spread at the topical test sites on the back of each participant.
OTHER	Sunscreen formulation S2	A total of 1.3 mg/cm2 of sunscreen formulation S2 will be applied to the test plates.
OTHER	Glycerin	A total of 1.3 mg/cm2 of glycerin will be applied to the test plates.

Timeline

• Start date: 2017-06-21
• Primary completion: 2017-07-07
• Completion: 2017-07-07
• First posted: 2017-05-17
• Last updated: 2019-07-22
• Results posted: 2019-07-22

Locations

1 site across 1 country: Germany