NCT00793026

Brief Summary

The purpose of this study is to prove the safety of the gynaecological formulation in normal conditions of use.

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

November 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2008

Completed
Last Updated

December 19, 2008

Status Verified

December 1, 2008

Enrollment Period

Same day

First QC Date

November 17, 2008

Last Update Submit

December 18, 2008

Conditions

Hygiene

Outcome Measures

Primary Outcomes (2)

  • Absence of irritation

    Throughout the study

  • Good acceptability

    Throughout the study

Study Arms (1)

1

EXPERIMENTAL

Dermacyd Breeze Pocket BR (Lactic Acid)

Drug: Dermacyd Breeze Pocket BR (Lactic Acid)

Interventions

Dermacyd Breeze Pocket BR (Lactic Acid)DRUG

Dermacyd Breeze Pocket BR (Lactic Acid) during 21 consecutive days

1

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Integral skin test in the region;
  • To use products of the same category;

You may not qualify if:

  • Lactation or gestation;
  • Use of anti-inflammatory, anti-histaminic or immunosuppressant drugs;
  • Cutaneous disease (local or spread) in the evaluation area;
  • Pathology which may cause immunity depression, such as HIV, diabetes;
  • Endocrine pathology
  • Solar exposure 15 days before evaluation;
  • Treatment until four months before the selection.
  • Allergic or atopic history to cosmetics products
  • 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 Administrative Office

São Paulo, Brazil

Location

Related Links

MeSH Terms

Interventions

Lactic Acid

Intervention Hierarchy (Ancestors)

LactatesHydroxy AcidsCarboxylic AcidsOrganic Chemicals

Study Officials

  • Jaderson Lima

    Sanofi

    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

November 17, 2008

First Posted

November 18, 2008

Study Start

November 1, 2008

Primary Completion

November 1, 2008

Last Updated

December 19, 2008

Record last verified: 2008-12

Locations

BR(1)