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Dermacyd Silver Floral (Lactic Acid) - Acceptability.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00933569
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : September 14, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:

Primary Objective:

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


Condition or disease Intervention/treatment Phase
Hygiene Drug: LACTIC ACID(ND) Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Dermacyd Silver Floral (Lactic Acid).
Study Start Date : June 2009
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Dermacyd Silver Floral (Lactic Acid)
Aplication of Dermacyd Silver Floral (Lactic Acid) during 21 consecutive days
Drug: LACTIC ACID(ND)
treatment period: 21 consecutive days


Outcome Measures

Primary Outcome Measures :
  1. 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) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933569


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

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00933569     History of Changes
Other Study ID Numbers: LACAC_L_04838
First Posted: July 7, 2009    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010