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Dermacyd Silver Floral (Lactic Acid) - Compatibility.

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00933712
First received: July 3, 2009
Last updated: September 13, 2010
Last verified: September 2010
History of Changes
  Purpose

Primary Objective:

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


Condition Intervention Phase
Hygiene
 Drug: LACTIC ACID(ND)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study for Dermatological Evaluation of Topic Compatibility. Primary and Accumulated Dermical Irritability and Dermical Sensitivity for the Product Dermacyd Silver Floral (Lactic Acid).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ]

Enrollment: 55
Study Start Date: June 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: LACTIC ACID(ND)
Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative for 6 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  • Disease which can cause immunosuppresion, such as diabetes, HIV
  • Use of Antihistamines 30 days before selection
  • Personnel 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933712

Locations
Brazil
Sanofi-Aventis Administrative Office
Sao Paulo, Brazil
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Jaderson Lima Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00933712     History of Changes
Other Study ID Numbers: LACAC_L_04839
Study First Received: July 3, 2009
Last Updated: September 13, 2010
Health Authority: Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on May 16, 2013