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OpenTrials
Completed

NCT Number: NCT00664391

Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Breeze

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

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Key information

Conditions

Hygiene

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-aventis

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Integral skin test in the region;

Exclusion criteria

  • 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.

Treatment and study plan

Lactic acid (Dermacid)

Drug

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

Primary outcomes

  1. Adverse events and their intensity and their association with the treatment.

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Breeze

Important dates

Study start
2008
Primary completion
2008
First posted
Apr 22, 2008
Registry last updated
Feb 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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