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Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00785642 |
To prove the safety of the gynaecological formulation in normal conditions of use.
Condition | Intervention | Phase |
---|---|---|
Hygiene |
Drug: Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Safety Dermatological Evaluation: Vaginal Mucous Irritation - Product Tested: Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid). |
Enrollment: | 30 |
Study Start Date: | August 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid)
|
Drug: Dermacyd PH_DETINLYN Tangerine Mix (Lactic Acid) |
Ages Eligible for Study: | 10 Years to 20 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | LACAC_L_04304 |
Study First Received: | November 4, 2008 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00785642 |
Health Authority: | Brazil: National Health Surveillance Agency |