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Completed

NCT Number: NCT00793026

Dermacyd Breeze Pocket BR (Lactic Acid) - Acceptability

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

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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 Administrative Office

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;
  • To use products of the same category;

Exclusion criteria

  • 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.

Treatment and study plan

Dermacyd Breeze Pocket BR (Lactic Acid)

Drug

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

Primary outcomes

  1. Absence of irritation

    Time frame: Throughout the study

  2. Good acceptability

    Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Safety Dermatological Evaluation: Genital Mucous Irritation - Test in Use - Dermacyd Breeze Pocket BR (Lactic Acid).

Important dates

Study start
2008
Primary completion
2008
First posted
Nov 18, 2008
Registry last updated
Dec 19, 2008

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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