Patch Test Skin Irritation/Sensitization of Cetaphil Daily Advance Ultra Hydration Lotion

July 28, 2022 updated by: Galderma R&D

100 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)

Determine if Cetaphil Daily Advance Ultra Hydrating Lotion proves to be a contact sensitizer or irritant in certain individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Not currently under a doctor's care
  • Free of dermatological or systemic disorder which would interfere with the results
  • Free of any acute or chronic disease
  • Will complete a preliminary medical history form and are in general good health
  • Can read, understand, and sign informed consent

Exclusion Criteria:

  • Under 18 years old
  • Currently under doctor's care
  • currently taking any medication
  • History of acute or chronic disease
  • Diagnosed with chronic skin allergies
  • Pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cetaphil Daily Advance Ultra Hydrating Lotion
All subjects receive Cetaphil Daily Advance Ultra Hydrating Lotion
Other: Cetaphil Daily Advance Ultra Hydrating Lotion
0.2ml or 0.2g of Cetaphil on occlusive, hypoallergenic patch applied to skin for 24 hrs 9 times on Monday, Wednesday, and Friday for 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
area of erythema and edema is measured
Time Frame: 3 consecutive weeks
9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks
3 consecutive weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

June 18, 2013

First Submitted That Met QC Criteria

June 19, 2013

First Posted (ESTIMATE)

June 24, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLI.04.SRE.US10232a

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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