Dermacyd PH_DESILSTY_FL (Lactic Acid) - Acceptability - Stay on Floral.

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00933699
First received: July 3, 2009
Last updated: September 13, 2010
Last verified: September 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up - Dermacyd PH_DESILSTY_FL (Lactic Acid).

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The absence of irritation and the good acceptability will be evaluated 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: 32
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
Experimental: Dermacyd PH_DESILSTY_FL (Lactic Acid)
Treatment duration: 21 consecutive days
Drug: LACTIC ACID(ND)
Treatment duration: 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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933699

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

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00933699     History of Changes
Other Study ID Numbers: LACAC_L_04803
Study First Received: July 3, 2009
Last Updated: September 13, 2010
Health Authority: Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on August 20, 2014