Repeat Insult Patch Test for Daily Advance Cetaphil Moisturizing Lotion

Skin Irritation Clinical Trial

Official title:

Daily Advance Cetaphil Moisturizing Lotion: Human Repeat Insult Patch Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892423
• Other study ID #: GLI.04SPR.US10044
• Status: Completed
• Phase: N/A
• Start date: August 2006

Study information

• Verified date: June 2013
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. primary completion date: September 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Skin Irritation

Intervention

Other:
• Cetaphil Moisturizing Lotion Daily Advance

Locations

Country	Name	City	State
United States	Thomas J Stephens and Associates Inc	Carrollton	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irritation responses	all patients will be assessed at 14 visits for redness (erythema), spreading, weeping, papules, vesicles, and bullae at application site	average of 5 weeks