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

NCT03157583 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-07-22

Study results available
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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.

Conditions

  • Sunscreening Agents

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

  • GSK Clinical Trials · GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-21
Primary Completion
2017-07-07
Completion
2017-07-07

Countries

  • Germany

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03157583 on ClinicalTrials.gov