NCT00663325

Brief Summary

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Tina Gel Sweet Flower.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
Last Updated

January 8, 2009

Status Verified

January 1, 2009

Enrollment Period

1 month

First QC Date

April 18, 2008

Last Update Submit

January 7, 2009

Conditions

Hygiene

Outcome Measures

Primary Outcomes (1)

  • Adverse events and their intensity and their association with the treatment

    21 days

Study Arms (1)

1

EXPERIMENTAL

Lactic acid in small quantity during 21 days

Drug: Lactic acid (Dermacid)

Interventions

Lactic acid (Dermacid)DRUG

Liquid soup to be applied in the external genital area, in a small quantity, with abundantly rinse after use, during 21 days.

1

Eligibility Criteria

Age10 Years - 20 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Integral skin test in the region;

You may not qualify if:

  • Lactation or gestational risk or gestation;
  • Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;
  • Topical medication use at the region to be treated;
  • Cutaneous disease or active gynecological disease which may interfere in study results;
  • Personal history of allergic disease at the area to be treated;
  • Allergic or atopic history;
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-aventis

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Interventions

Lactic Acid

Intervention Hierarchy (Ancestors)

LactatesHydroxy AcidsCarboxylic AcidsOrganic Chemicals

Study Officials

  • Jaderson Lima

    Sanofi-aventis administrative office Brazil

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 22, 2008

Study Start

December 1, 2007

Primary Completion

January 1, 2008

Last Updated

January 8, 2009

Record last verified: 2009-01

Locations

BR(1)