Hygiene Clinical Trial
Official title:
Safety Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensibility) of Dermacyd Wipes
NCT number | NCT00371852 |
Other study ID # | LACTO_L_01811 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | August 31, 2006 |
Last updated | May 15, 2008 |
Start date | May 2006 |
Verified date | May 2008 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Brazil: National Health Surveillance Agency |
Study type | Interventional |
The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd wipes.
Status | Completed |
Enrollment | 50 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Phototypes: I, II, III and IV; - Integral skin test in the region; Exclusion Criteria: - Lactation or gestation - Use of Anti-inflammatory and/or immune-suppression drugs - Personnel history of atopy; - History of sensibilization or irritation for topic products; - Active cutaneous disease; - Use of new drugs and/or cosmetics during the study |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Sanofi-aventis | São Paulo |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG) |
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