Skin Irritation
Conditions
Brief summary
Human repeat insult patch test to assess the potential for Cetaphil Moisturizing Lotion Daily Advance to induce sensitization to the skin
Interventions
OTHERCetaphil Moisturizing Lotion Daily Advance
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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 * individuals with uncontrolled metabolic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed