Repeat Insult Patch Test for Daily Advance Cetaphil Moisturizing Lotion

Not Applicable

Completed

• Conditions: Skin Irritation
• Interventions: Other: Cetaphil Moisturizing Lotion Daily Advance

• Registration Number: NCT01892423
• Lead Sponsor: Galderma R&D

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Primary Completion: 2006-09
• Status Verified: 2013-06
• Study First Submitted: 2013-06-26
• Study First Submitted QC: 2013-07-01
• Study First Posted: 2013-07-04
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cetaphil Moisturizing Lotion Daily Advance	Cetaphil Moisturizing Lotion Daily Advance	Each subject had Cetaphil Moisturizing Lotion Daily Advance applied

Primary Outcome Measures

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

Trial Locations

Locations (1)

Thomas J Stephens and Associates Inc; 🇺🇸 Carrollton, Texas, United States