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To Evaluate Skin Irritation and Skin Sensitisation of Developmental Cosmetic Facial Products

NCT04007159 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2020-12-10

Study results available
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Summary

The aim of this study is to assess irritant or allergic response of 3 developmental cosmetic facial products following a conventional human repeated insult patch test methodology for 6 weeks.

Conditions

  • Skin Care

Interventions

OTHER

Serum

Participants will be topically applied serum to the dorsum, under a semi-occlusive patch (0.02 milliliters per centimeters square \[mL/cm\^2\] of serum in an individual cell of patch)

OTHER

Lotion

Participants will be topically applied lotion to the dorsum, under a semi-occlusive patch (0.02mL/cm\^2 of lotion in an individual cell of patch)

OTHER

Cream

Participants will be topically applied cream to the dorsum, under a semi-occlusive patch (0.02mL/cm\^2 of cream in an individual cell of patch)

OTHER

Normal Saline

Participants will be topically applied normal saline to the dorsum, under a semi-occlusive patch (0.02mL/cm\^2 of normal saline in an individual cell of patch)

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
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-08-30
Primary Completion
2019-11-29
Completion
2019-11-29

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 NCT04007159 on ClinicalTrials.gov