Determine Sensitivity of Skin to Cetaphil Daily Advance Ultra Hydrating Lotion Clinical Trial
Official title:
100 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)
| NCT number | NCT01885130 |
| Other study ID # | GLI.04.SRE.US10232a |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | December 2012 |
| Verified date | June 2013 |
| Source | Galderma R&D |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Determine if Cetaphil Daily Advance Ultra Hydrating Lotion proves to be a contact sensitizer or irritant in certain individuals.
| Status | Completed |
| Enrollment | 100 |
| Est. completion date | |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Not currently under a doctor's care - Free of dermatological or systemic disorder which would interfere with the results - Free of any acute or chronic disease - Will complete a preliminary medical history form and are in general good health - Can read, understand, and sign informed consent Exclusion Criteria: - Under 18 years old - Currently under doctor's care - currently taking any medication - History of acute or chronic disease - Diagnosed with chronic skin allergies - Pregnant or lactating |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Galderma R&D |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | area of erythema and edema is measured | 9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks | 3 consecutive weeks |