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
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 April 17, 2014