Dermacyd Silver Floral (Lactic Acid) - Acceptability.

Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynaecological Follow up Dermacyd Silver Floral (Lactic Acid).

Primary Objective:

To prove the safety of the gynaecological formulation in normal conditions of use.

Study Overview

• Status: Completed
• Conditions: Hygiene
• Intervention / Treatment: Drug: LACTIC ACID(ND)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion criteria:

• Integral vaginal mucosa in the product analysis region
• Use the same category of cosmetics products
• Willingness in following the study procedures and to be present in the clinic at the days and scheduled time

Exclusion criteria:

• Use of Anti-inflammatory, immunossupression or antihistaminics drugs
• Allergic or atopic history to cosmetics products
• Cutaneous active disease (local and/or general) in the evaluated area
• Disease which can cause immunosuppresion, such as diabetes, HIV
• Endocrinology pathology such as thyroid gland, ovary and adrenal gland
• Intensive solar exposure until 15 days before evaluation
• Gynecological treatment until four weeks before the study
• Other reason considered by the investigator as a reason for not being included.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dermacyd Silver Floral (Lactic Acid); Aplication of Dermacyd Silver Floral (Lactic Acid) during 21 consecutive days	Drug: LACTIC ACID(ND); treatment period: 21 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction.	From the treatment start to the end of the study (treatment period 21 days)

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: July 3, 2009
• First Submitted That Met QC Criteria: July 3, 2009
• First Posted (Estimate): July 7, 2009

Study Record Updates

• Last Update Posted (Estimate): September 14, 2010
• Last Update Submitted That Met QC Criteria: September 13, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: LACAC_L_04838