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OpenTrials
Completed

NCT Number: NCT00783861

Dermacyd Femina (Lactic Acid) Pocket BR - Compatibility

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Femina (Lactic Acid) Pocket BR.

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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

  • Age between 18 and 60 years old;
  • 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 and/or immunosuppression drugs one month before the study;
  • Personnel history of atopy;
  • History of sensitivity or irritation for topic products;
  • Active cutaneous disease;
  • Use of new drugs or cosmetics during the study;

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

Drug

Lactic Acid (Dermacyd Femina)

Primary outcomes

  1. The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.

    Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Femina Pocket BR.

Important dates

Study start
2008
Primary completion
2008
First posted
Nov 3, 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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