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OpenTrials
Completed

NCT Number: NCT00933075

Dermacyd Silver Frutal (Lactic Acid) - Photo Evaluation.

Primary Objective:

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Silver Frutal.

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 II and III 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 pregnancy
  • Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection
  • Diseases which can cause immunosuppresion, such as diabetes, HIV
  • Use of photosensitivity drugs
  • History of sensitivity or photosensitivity for topic products
  • Cutaneous active disease which can modify the study results
  • History or activity of photodermatosis
  • Personal or family antecedents of cutaneous neoplasia photo induced
  • Presence of injury precursor of cutaneous neoplasia, such as melanociticos nevus and actinic keratosis
  • Intense exposure solar in the test region
  • Use of new drugs and/or cosmetics during the study
  • Previous participation in studies using the same product in test
  • 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

Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 5 weeks (treatment period).

Primary outcomes

  1. Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according to International Contact Dermatitis Research Group (ICDRG) scale. Evaluation of the sensibility according to the skin type.

    Time frame: From the treatment start to the end of the study (treatment period 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 Silver Frutal (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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