Repeat Insult Patch Test for Daily Advance Cetaphil Moisturizing Lotion

July 28, 2022 updated by: Galderma R&D

Daily Advance Cetaphil Moisturizing Lotion: Human Repeat Insult Patch Test

Human repeat insult patch test to assess the potential for Cetaphil Moisturizing Lotion Daily Advance to induce sensitization to the skin

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Carrollton, Texas, United States, 75006
        • Thomas J Stephens and Associates Inc

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 to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-65 years
  • Good health
  • willingness to cooperate and participate
  • willingness to avoid topical products at test sites
  • willingness to avoid direct sun exposure to test sites

Exclusion Criteria:

  • Individuals with active psoriasis or eczema
  • individuals with sunburn, acne, abrasions, scar tissue, or tattoos on test sites, or disease of skin that might interfere
  • individuals who have had a mastectomy with axillary nodes were removed
  • individuals receiving anticancer, immunosuppressive treatments or medications, or radiation
  • pregnant, nursing, or planned to become pregnant
  • use of topical steroids or drugs at test sites
  • active or untreated skin cancer
  • active hepatitis
  • current routine or frequent use of high doses of anti-inflammatory drugs
  • individuals who have had les than two week rest period since completion of previous patch testing on upper back or upper arms
  • individuals with uncontrolled metabolic diseases

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 Moisturizing Lotion Daily Advance
Each subject had Cetaphil Moisturizing Lotion Daily Advance applied
Other: Cetaphil Moisturizing Lotion Daily Advance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Irritation responses
Time Frame: average of 5 weeks
all patients will be assessed at 14 visits for redness (erythema), spreading, weeping, papules, vesicles, and bullae at application site
average of 5 weeks

Collaborators and Investigators

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

Sponsor

Galderma R&D

Investigators

  • Principal Investigator: James H Herndon, MD, FAAD

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

August 1, 2006

Primary Completion (ACTUAL)

September 1, 2006

Study Registration Dates

First Submitted

June 26, 2013

First Submitted That Met QC Criteria

July 1, 2013

First Posted (ESTIMATE)

July 4, 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

Other Study ID Numbers

  • GLI.04SPR.US10044

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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