Dermacyd in Odor Reducing.

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT01158365
First received: July 7, 2010
Last updated: January 3, 2011
Last verified: January 2011
  Purpose

Primary Objective:

- To prove the efficacy superiority in reducing the genital odor and increase hydration in mucosa genital comparing the use of Dermacyd (different fragrances) and Glycerine Vegetal Soap Granado Traditional

Secondary Objective:

- To evaluate the safety in normal conditions of use, verifying clinical signs and lab exams.


Condition Intervention Phase
Hygiene
Drug: LACTIC ACID (Dermacid)
Drug: Glycerine Vegetal Soap Granado Traditional
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Center, Open, Cross-over, Phase III Study for Comparative Evaluation of Safety Use and Efficacy in the Odor Reduce and Vaginal Moisturize Increase for Intimates Use Products Dermacyd Femina Delicata, Dermacyd Femina Breeze, Dermacyd Teen Sweet Flower, Dermacyd Teen Fresh Mix and Dermacyd Femina Comparing to the Control Product Glycerine Vegetal Soap Granado Traditional.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Reduction of genital odor and increase hydration in genital mucosa [ Time Frame: From the treatment start to the end of the study (day 67) ] [ Designated as safety issue: No ]
    Patient's questionnaire will be completed at V1, V2 and V4. Reduction of vaginal odor, increase in the moisture area, and perception about some items like foam, facility of rinsing, final touch of the mucosa, final fragrance, and cleaning sensation will be rated on a 5-point scale.


Secondary Outcome Measures:
  • Evaluation of the integrity of the mucosa [ Time Frame: From the treatment start to the end of the study (day 67) ] [ Designated as safety issue: Yes ]
    Onset of erythema, edema, scaling, blisters or other clinical sign will be evaluated.


Enrollment: 230
Study Start Date: July 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dermacyd (different fragrances)
Day 1 until 30: Investigational Product (Dermacyd) Day 31 until 37: wash-out Day 38 until 67: Glycerine Vegetal Soap Granado Traditional
Drug: LACTIC ACID (Dermacid)
Route of administration: local
Drug: Glycerine Vegetal Soap Granado Traditional
Route of administration: local
Active Comparator: Glycerine Vegetal Soap Granado Traditional
Day 1 until 30: Glycerine Vegetal Soap Granado Traditional Day 31 until 37: wash-out Day 38 until 67: Investigational Product (Dermacyd)
Drug: LACTIC ACID (Dermacid)
Route of administration: local
Drug: Glycerine Vegetal Soap Granado Traditional
Route of administration: local

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Perfect mucosa in the product analysis region
  • Volunteers with active sexual life: normal Papanicolau test performed less than one year is mandatory
  • Bacterioscopy describing the vaginal flora
  • Negative Trichomonas vaginalis test
  • Negative Whiff test
  • Willingness in using preservative in the sexual intercourse during the study period
  • 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 for medical evaluations and for application of occlusion

Exclusion criteria:

  • Use of antiinflammatory / immunosuppression / antihistaminic drugs
  • Atopic or allergy history to cosmetic products
  • Active cutaneous disease (local and/or disseminated) in the evaluated area
  • Disease which can cause immunosuppression, such as diabetes, HIV, etc.
  • Endocrine pathology such as thyroid disease, ovarian or adrenal gland disturbs
  • Intense solar exposure (to get a tan) during the 15 days before the evaluation
  • Gynecologic treatment until four weeks before the evaluation
  • Any vaginal infection detected during the inclusion
  • Other conditions considered by the investigator as reasonable for exclude the patient in the study.

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: NCT01158365

Locations
Brazil
Sanofi-Aventis Investigational Site Number 076-001
Osasco, Brazil, 06023-000
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT01158365     History of Changes
Other Study ID Numbers: LACAC_L_05401, U1111-1115-3484
Study First Received: July 7, 2010
Last Updated: January 3, 2011
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014