Dermacyd Silver Frutal (Lactic Acid) - Compatibility.

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00933946
First received: July 3, 2009
Last updated: September 13, 2010
Last verified: September 2010

July 3, 2009
September 13, 2010
June 2009
July 2009   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00933946 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dermacyd Silver Frutal (Lactic Acid) - Compatibility.
Study for Dermatological Evaluation of Topic Compatibility Primary and Accumulated Dermical Irritability and Dermical Sensitivity for the Product Dermacyd Silver Frutal (Lactic Acid).

Primary Objective:

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

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hygiene
Drug: LACTIC ACID(ND)
Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 21 consecutive days.
Experimental: Dermacyd Silver Frutal (Lactic Acid)
Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also used as a control sample.
Intervention: Drug: LACTIC ACID(ND)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
July 2009
July 2009   (final data collection date for primary outcome measure)

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 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
  • Personal 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 reaction
  • 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.

Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00933946
LACAC_L_04842
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Jaderson Lima Sanofi
Sanofi
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP