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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

July 7, 2010
January 3, 2011
July 2010
December 2010   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01158365 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Dermacyd in Odor Reducing.
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Hygiene
  • Drug: LACTIC ACID (Dermacid)
    Route of administration: local
  • Drug: Glycerine Vegetal Soap Granado Traditional
    Route of administration: local
  • 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
    Interventions:
    • Drug: LACTIC ACID (Dermacid)
    • Drug: Glycerine Vegetal Soap Granado Traditional
  • 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)
    Interventions:
    • Drug: LACTIC ACID (Dermacid)
    • Drug: Glycerine Vegetal Soap Granado Traditional
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
230
December 2010
December 2010   (final data collection date for primary outcome measure)

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.

Female
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01158365
LACAC_L_05401, U1111-1115-3484
Not Provided
Trial Transparency Team, sanofi-aventis
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
January 2011

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