Comparative Safety and Efficacy Evaluation Between Dermacyd Silver and Glycerine Vegetal Soap Granado Traditional

NCT01126606 | Completed Phase 3

• 1 other identifier: LACAC_L_04937
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To evaluate the potential of hydratation and renewal of the mucosa, through corneometry measurement and individual questionnaire perception. Secondary Objective: To evaluate the safety in normal condition of use.

Conditions

Hygiene

Outcome Measures

Primary Outcomes (1)

• Transepidermal water loss measurement (TEWL) and corneometry

  Measures taken at all visits by Tewameter equipment TM 300. The value of the average will be considered for analysis of final results. Corneometry: Measures taken at all visits by Corneometer equipment MPA 580.

  Up to Week 9

Study Arms (2)

Group 1

EXPERIMENTAL

Dermacyd Silver Frutal followed by Dermacyd Silver Frutal+PH\_DESYLSTY\_FR followed by wash out followed by Glycerine Vegetal Soap Granado Traditional

Drug: Dermacid Silver (Lactic acid); Drug: Glycerine Vegetal Soap Granado Traditional

Group 2

EXPERIMENTAL

Glycerine Vegetal Soap Granado Traditional followed by wash out followed by Dermacyd Silver Floral followed by Dermacyd Silver Floral + PH\_DESYLSTY\_FR

Drug: Dermacid Silver (Lactic acid); Drug: Glycerine Vegetal Soap Granado Traditional

Interventions

Dermacid Silver (Lactic acid) DRUG

Liquid soap, daily use

Group 1; Group 2

Glycerine Vegetal Soap Granado Traditional DRUG

Vegetal soap, daily use

Group 1; Group 2

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active sex life
• Menopause for at least 6 months
• Perfect mucosa in the evaluated area
• Use the same cosmetics category

You may not qualify if:

• Use of antiinflammatory / immunosuppression / antihistaminic drugs
• Personal history of atopy to cosmetic products
• Cutaneous active disease (local and/or general) in the evaluated area
• Disease which can cause immunosuppression, such as diabetes, HIV
• Endocrine pathology such as thyroid disease, ovarian disorder or adrenal gland
• Intense solar exposure (to get a tan) during the 15 days before the evaluation
• Gynaecologic treatment until four weeks before the evaluation
• Other conditions considered by the investigator as reasonable to exclude the patient from 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 Administrative Office

São Paulo, 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: May 17, 2010
• First Posted: May 19, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 2, 2010

Record last verified: 2010-12

Locations

BR (1)