Sanofi-Aventis Investigational Site Number 076-001
Osasco, 06023-000, Brazil
NCT Number: NCT01158365
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.
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Notify Me18 year–45 year
Female
Interventional
Phase 3
Osasco, 06023-000, Brazil
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Route of administration: local
Route of administration: local
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.
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.
Sanofi
Industry
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.
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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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