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OpenTrials
Completed

NCT Number: NCT00705276

Dermacyd Femina Delicata (Lactic Acid)- Photo Dermatological Evaluation of the Irritation and Sensitivity Potential

To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina Delicata.

Completed

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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

  • Phototype Skin II and III;
  • Integral skin test in the region;

Exclusion criteria

  • Lactation or gestation;
  • Use of Anti-inflammatory and/or immuno-suppression drugs 15 days before the selection;
  • Diseases which can cause immunity decrease, such as HIV, diabetes;
  • Use of drug photosensitizer;
  • History of sensitivity or irritation for topic products;
  • Active cutaneous disease which can change the study results;
  • History or photodermatosis active;
  • Family or personal antecedent of cutaneous photoinduced neoplasias;
  • Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium;
  • Intense solar exposure in the study area;
  • 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 (Dermacyd Femina Delicata)

Drug

Primary outcomes

  1. The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale.

    Time frame: 5 weeks

  2. The sensibility will be evaluated according the skin type.

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina Delicata

Important dates

Study start
2008
Primary completion
2008
First posted
Jun 26, 2008
Registry last updated
Apr 15, 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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