Dermacyd Silver Frutal (Lactic Acid) - Photo Evaluation.

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

Primary Objective:

To demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd Silver Frutal.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 3

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• 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 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	From the treatment start to the end of the study (treatment period 5 weeks)

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: July 3, 2009
• First Submitted That Met QC Criteria: July 3, 2009
• First Posted (Estimate): July 7, 2009

Study Record Updates

• Last Update Posted (Estimate): September 14, 2010
• Last Update Submitted That Met QC Criteria: September 13, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: LACAC_L_04843