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Dermacyd Silver Floral (Lactic Acid) - Acceptability.
This study has been completed.
First Received: July 3, 2009   Last Updated: September 4, 2009   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00933569
  Purpose

Primary Objective:

To prove the safety of the gynaecological formulation in normal conditions of use.


Condition Intervention Phase
Hygiene
 Drug: LACTIC ACID(ND)
 Phase III

Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title: Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Dermacyd Silver Floral (Lactic Acid).

Resource links provided by NLM:

Drug Information available for: Lactic acid Ammonium lactate
U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction. [ Time Frame: From the treatment start to the end of the study (treatment period 21 days) ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: June 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dermacyd Silver Floral (Lactic Acid): Experimental
Aplication of Dermacyd Silver Floral (Lactic Acid) during 21 consecutive days
Drug: LACTIC ACID(ND)
treatment period: 21 consecutive days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Integral vaginal mucosa in the product analysis region
  • Use the same category of cosmetics products
  • Willingness in following the study procedures and to be present in the clinic at the days and scheduled time

Exclusion criteria:

  • Use of Anti-inflammatory, immunossupression or antihistaminics drugs
  • Allergic or atopic history to cosmetics products
  • Cutaneous active disease (local and/or general) in the evaluated area
  • Disease which can cause immunosuppresion, such as diabetes, HIV
  • Endocrinology pathology such as thyroid gland, ovary and adrenal gland
  • Intensive solar exposure until 15 days before evaluation
  • Gynecological treatment until four weeks before the study
  • Other reason considered by the investigator as a reason for not being included.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933569

Locations
Brazil
Sanofi-aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Jaderson Lima Sanofi-Aventis
  More Information

No publications provided

Responsible Party: sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers: LACAC_L_04838
Study First Received: July 3, 2009
Last Updated: September 4, 2009
ClinicalTrials.gov Identifier: NCT00933569     History of Changes
Health Authority: Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on September 10, 2009



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