MedTrace Logo

A Photoxicity and Photoallergy Study of a Developmental Face Cream, Serum and Lotion

NCT04006795 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-08-13

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to demonstrate the absence of sensitisation and irritation potential of a product when applied to the skin and exposed to ultraviolet (UV) radiation. Photo-sensitisation potential will primarily be evaluated through a subsequent semi-occluded application and UV exposure (challenge phase) after a 2-week rest period. Photo-irritation potential will primarily be evaluated through the repeated occluded application and UV exposure of the study products over 3 weeks (induction phase).

Conditions

  • Skin Care

Interventions

OTHER

Serum

Participants will be topically applied adhesive patch containing developmental serum

OTHER

Lotion

Participants will be topically applied adhesive patch containing developmental lotion

OTHER

Cream

Participants will be topically applied adhesive patch containing developmental cream

OTHER

Normal Saline

Participants will be topically applied adhesive patch containing normal saline

Sponsors & Collaborators

Principal Investigators

  • 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
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-08-28
Primary Completion
2019-10-11
Completion
2019-10-11

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Companies

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 NCT04006795 on ClinicalTrials.gov