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OpenTrials
Completed

NCT Number: NCT01158365

Dermacyd in Odor Reducing.

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.

Completed

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Investigational Site Number 076-001

Osasco, 06023-000, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactic acid (Dermacid)

Drug

Route of administration: local

Glycerine Vegetal Soap Granado Traditional

Drug

Route of administration: local

Primary outcomes

  1. Reduction of genital odor and increase hydration in genital mucosa

    Time frame: From the treatment start to the end of the study (day 67)

    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 outcomes

  1. Evaluation of the integrity of the mucosa

    Time frame: From the treatment start to the end of the study (day 67)

    Onset of erythema, edema, scaling, blisters or other clinical sign will be evaluated.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 8, 2010
Registry last updated
Jan 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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