Dermacyd Infantile (Lactic Acid) - Photo Evaluation.

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

Primary Objective:

To demonstrate the absence of photo irritation and photosensitization potential of the product Dermacyd Infantile (Lactic Acid).

Study Overview

• Status: Completed
• Conditions: Hygiene
• Intervention / Treatment: Drug: LACTIC ACID(ND)

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Phototype Skin I, II, III and 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:

• Use of Anti-inflammatory, immunosuppressant or anti-histaminic drugs
• Lactation or gestation
• Use of Anti-inflammatory drugs 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.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dermacyd infantile (Lactic Acid); 5 weeks treatment	Drug: LACTIC ACID(ND); Dermacyd infantile (Lactic Acid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale. The sensibility will be evaluated according to the skin type.	During 5 weeks (i.e. treatment period)

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: April 10, 2009
• First Submitted That Met QC Criteria: April 14, 2009
• First Posted (Estimate): April 15, 2009

Study Record Updates

• Last Update Posted (Estimate): April 15, 2009
• Last Update Submitted That Met QC Criteria: April 14, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: LACAC_L_04680