Hygiene Clinical Trial
Official title:
Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensitivity) of Dermacyd Delicata (New Fragrance)
NCT number | NCT00380991 |
Other study ID # | LACTO_L_01840 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | September 25, 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 potential irritation (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Delicata (new fragrance of Dermacyd)
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: - Phototype Skin I,II, III and IV - Integral skin test in the region; Exclusion Criteria: - Lactation or gestation - Use of Antiinflammatory and/or immunosuppression drugs - Personal history of atopy; - History of sensibilization or irritation for topic products; - Active cutaneous disease; - Use of new drugs 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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