MedTrace Logo

To Investigate Primary Irritation Potential of Four Skin Serum Products on Human Subjects Assessed by 24 Hour Patch Test

NCT03233009 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2019-01-16

Study results available
· View outcomes & findings →

Summary

To assess the irritation potential of four prototype daily defense serum formulations after 24 (± 2) hours under semi-occlusive patch application to the skin of healthy volunteers.

Conditions

  • Skin Care

Interventions

OTHER

Experimental Daily Defense Serum A

Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).

OTHER

Experimental Daily Defense Serum C

Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).

OTHER

Experimental Daily Defense Serum G

Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).

OTHER

Experimental Daily Defense Serum N

Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).

OTHER

Saline Solution Sodium Chloride

Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).

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
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-05-22
Primary Completion
2017-05-26
Completion
2017-05-26

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 NCT03233009 on ClinicalTrials.gov