MedTrace Logo

To Assess the Cutaneous Irritation and Sensitization Potential of a Cosmetic Facial Product Using a Human Repeat Insult Patch Test (HRIPT) in Healthy Participants

NCT03175562 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2019-02-15

Study results available
· View outcomes & findings →

Summary

The objective of this clinical study is to assess the irritation and sensitisation potential of a cosmetic test product after repeated semi-occlusive patch applications to healthy human participants by following a conventional HRIPT methodology under supervision of a dermatologist.

Conditions

  • Skin Care

Interventions

OTHER

Facial micellar cleanser

Participant will have each product applied topically via semi occlusive patch, on site by the technician. Each patch will remain in place for 48 (± 2) hours on weekdays and 72 (± 2) hours on weekends.

OTHER

Saline Solution: Sodium Chloride (NaCl; 0.9%)

Participant will have each product applied topically via semi occlusive patch, on site by the technician. Each patch will remain in place for 48 (± 2) hours on weekdays and 72 (± 2) hours on weekends.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

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
2017-03-27
Primary Completion
2017-05-19
Completion
2017-05-19

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 NCT03175562 on ClinicalTrials.gov