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Dermacyd PH_DESILSTY_FR (Lactic Acid) - Acceptability - Stay on Frutal

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00932945
First received: July 3, 2009
Last updated: September 13, 2010
Last verified: September 2010
History of Changes

July 3, 2009
September 13, 2010
June 2009
July 2009   (final data collection date for primary outcome measure)
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 up to the end of the study (treatment period 21 days) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00932945 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dermacyd PH_DESILSTY_FR (Lactic Acid) - Acceptability - Stay on Frutal
Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up - Dermacyd PH_DESILSTY_FR (Lactic Acid).

Primary Objective:

To prove the safety of the gynecological formulation in normal conditions of use.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Hygiene
Drug: LACTIC ACID(ND)
Treatment duration: 21 consecutive days
Experimental: Dermacyd PH_DESILSTY_FR (Lactic Acid)
Treatment duration: 21 consecutive days
Intervention: Drug: LACTIC ACID(ND)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
July 2009
July 2009   (final data collection date for primary outcome measure)

Exclusion 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.
Female
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00932945
LACAC_L_04806
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Jaderson Lima Sanofi
Sanofi
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP