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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00784121 |
To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Breeze (Lactic Acid) Pocket BR.
Condition | Intervention | Phase |
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Hygiene |
Drug: Lactic Acid |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Breeze Pocket BR. |
Enrollment: | 54 |
Study Start Date: | October 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Lactic Acid (Dermacyd Breeze)
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Drug: Lactic Acid
Lactic Acid (Dermacyd Breeze)
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | LACAC_L_04366 |
Study First Received: | October 31, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00784121 |
Health Authority: | Brazil: National Health Surveillance Agency |