Dermacyd Infantile (Lactic Acid)- Compatibility.

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00881374
First received: April 10, 2009
Last updated: April 14, 2009
Last verified: April 2009
  Purpose

Primary Objective:

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergic potential (sensibilization) of the product Dermacyd Infantile.


Condition Intervention Phase
Hygiene
Drug: LACTIC ACID(ND)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermic Irritability, Dermic Sensitivity) of Dermacyd Infantile (Lactic Acid).

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • The absence of primary and accumulated dermic irritability and dermic sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale. [ Time Frame: During 6 weeks (i.e. treatment period) ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: February 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dermacyd Infantile (Lactic Acid)
six weeks treatment
Drug: LACTIC ACID(ND)
Dermacyd Infantile (Lactic Acid)

  Eligibility

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

Inclusion criteria:

  • Photo type 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 gestation
  • Use of Anti-inflammatory 30 days and/or immunosuppressant drugs during 3 months before the selection
  • Diseases which can cause immunity decrease, such as HIV, diabetes
  • Previous atopy
  • History of sensitivity or irritation for topic products
  • Active cutaneous diseases which can interfere in the study results
  • Use of new drugs and/ or cosmetics during the study
  • Cutaneous reactivity
  • Previous participation in studies, which had used the product
  • Volunteers who have immunodeficiency congenital or acquired
  • Relevant clinical history or present evidence of alcohol abuse or others drugs
  • Non tolerance to some component of the study product.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881374

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: NCT00881374     History of Changes
Other Study ID Numbers: LACAC_L_04679
Study First Received: April 10, 2009
Last Updated: April 14, 2009
Health Authority: Brazil: National Health Surveillance Agency

ClinicalTrials.gov processed this record on July 23, 2014