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OpenTrials
Completed

NCT Number: NCT00881270

Dermacyd Infantile - Acceptability.

Primary Objective:

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

Completed

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Key information

Conditions

Hygiene

Age range

Up to 12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

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
  • Use the same category of cosmetics
  • 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, immunosuppressant or anti-histaminic drugs
  • Allergic or atopic history to cosmetics products
  • Cutaneous active disease (local or general) in the evaluated area
  • Disease which can cause immunosuppressant, such as diabetes, HIV
  • Endocrine pathology
  • Intensive solar exposure until 15 days before evaluation
  • Treatment four months before selection.

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(ND)

Drug

Dermacyd Infantile (LACTIC ACID)

Primary outcomes

  1. The absence of irritation and the good acceptability will be evaluated using one specific scale which describes the intensity of the reaction.

    Time frame: From the treatment start to the end of the study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Safety Dermatological Evaluation: Acceptability With Paediatric Follow up Dermacyd Infantile (Lactic Acid).

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 15, 2009
Registry last updated
Sep 28, 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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