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Completed

NCT Number: NCT00933907

Dermacyd PH_DESILSTY_FR (Lactic Acid) - Compatibility - Stay on Frutal

Primary Objective:

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDESILSTYFR.

Completed

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Key information

Conditions

Hygiene

Age range

18 year–60 year

Sex eligibility

All sexes

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

  • Phototype Skin I,II, III e IV Integral skin test in the region
  • Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria

  • Lactation or gestation
  • Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
  • Disease which can cause immunosuppresion, such as diabetes, HIV
  • Personnel history of atopy
  • History of sensitivity or irritation for topic products
  • Cutaneous active disease (local and/or general) which can modify the study results
  • Use of new drugs and/or cosmetics during the study
  • Cutaneous reactive
  • Previous participation in studies using the same product in test
  • Volunteer which has immunodeficiency congenital or acquired
  • Relevant history or confirmation of alcohol or other drugs abuse
  • Intolerance detected or suspected for some component of the sample tested
  • Medecin or sponsor employees or their close family.

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

Treatment duration: 6 weeks

Primary outcomes

  1. Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale.

    Time frame: From the treatment start to the end of the study( treatment period 6 weeks)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Study Title: Study for Dermatological Evaluation of Topic Compatibility Primary and Accumulated Dermical Irritability and Dermical Sensitivity for the Product Dermacyd PH_DESILSTY_FR (Lactic Acid) .

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 7, 2009
Registry last updated
Sep 14, 2010

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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