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Dermacyd Silver Floral (Lactic Acid) - Photo Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00932984
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : September 14, 2010
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE July 3, 2009
First Posted Date  ICMJE July 7, 2009
Last Update Posted Date September 14, 2010
Study Start Date  ICMJE June 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2009)
Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00932984 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dermacyd Silver Floral (Lactic Acid) - Photo Evaluation
Official Title  ICMJE Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Silver Floral (Lactic Acid).
Brief Summary

Primary Objective:

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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hygiene
Intervention  ICMJE Drug: LACTIC ACID(ND)
Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative during 5 weeks (treatment period).
Study Arms  ICMJE Experimental: Dermacyd Silver Floral (Lactic Acid)
Dermacyd Silver Floral (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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 4, 2009)
27
Original Actual Enrollment  ICMJE
 (submitted: July 3, 2009)
20
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • Disease which can cause immunosuppresion, such as diabetes, HIV
  • Concomitant use of photosensitivity drugs
  • History of sensitivity or photosensitivity withr 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00932984
Other Study ID Numbers  ICMJE LACAC_L_04840
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical Affairs Study Director, sanofi-aventis
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jaderson Lima Sanofi
PRS Account Sanofi
Verification Date September 2010

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