Dermacyd in Odor Reducing.

NCT01158365 | Completed Phase 3

• 2 other identifiers: LACAC_L_05401U1111-1115-3484
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hygiene

Outcome Measures

Primary Outcomes (1)

• Reduction of genital odor and increase hydration in genital mucosa

  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.

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

Secondary Outcomes (1)

• Evaluation of the integrity of the mucosa

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

Study Arms (2)

Dermacyd (different fragrances)

EXPERIMENTAL

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); Drug: Glycerine Vegetal Soap Granado Traditional

Glycerine Vegetal Soap Granado Traditional

ACTIVE COMPARATOR

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); Drug: Glycerine Vegetal Soap Granado Traditional

Interventions

LACTIC ACID (Dermacid) DRUG

Route of administration: local

Dermacyd (different fragrances); Glycerine Vegetal Soap Granado Traditional

Glycerine Vegetal Soap Granado Traditional DRUG

Route of administration: local

Dermacyd (different fragrances); Glycerine Vegetal Soap Granado Traditional

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Investigational Site Number 076-001

Osasco, 06023-000, Brazil

Location

MeSH Terms

Interventions

Lactic Acid

Intervention Hierarchy (Ancestors)

Lactates; Hydroxy Acids; Carboxylic Acids; Organic Chemicals

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 8, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 4, 2011

Record last verified: 2011-01

Locations

BR (1)