NCT01892423
Completed
Not Applicable
Daily Advance Cetaphil Moisturizing Lotion: Human Repeat Insult Patch Test
ConditionsSkin Irritation
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Galderma R&D
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- Irritation responses
Overview
Brief Summary
Human repeat insult patch test to assess the potential for Cetaphil Moisturizing Lotion Daily Advance to induce sensitization to the skin
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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