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Dermacyd Silver Frutal (Lactic Acid) - Photo Evaluation.

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00933075
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 photoirritation and photosensitization potential of the product Dermacyd Silver Frutal.


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: Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Silver Frutal (Lactic Acid).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 27
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 Frutal (Lactic Acid)
Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also usedas a control sample.
 Drug: LACTIC ACID(ND)
Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 5 weeks (treatment period).

  Eligibility

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

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933075

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: NCT00933075     History of Changes
Other Study ID Numbers: LACAC_L_04843
Study First Received: July 3, 2009
Last Updated: September 13, 2010
Health Authority: Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on June 17, 2013