Dermacyd PH_DETINLYN (Lactic Acid) Tangerine Mix - Compatibility

Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINLYN (Lactic Acid) Tangerine Mix

The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDETINLYN Tangerine Mix.None.

Study Overview

• Status: Completed
• Conditions: Hygiene
• Intervention / Treatment: Drug: Dermacyd PH_DETINLYN (Lactic Acid)

• Study Type: Interventional
• Enrollment (Actual): 53
• 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: Female

Description

Inclusion criteria:

• Phototype 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 inclusion:

• Lactation or gestation
• Use of Antiinflammatory and/or immunossupression drugs
• Personnel history of atopy;
• History of sensitivity or irritation for topic products;
• Active cutaneous disease;
• Use of new drugs or cosmetics during the study

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: 1; Dermacyd PH_DETINLYN (Lactic Acid)	Drug: Dermacyd PH_DETINLYN (Lactic Acid)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.	Throughout the study

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: November 4, 2008
• First Submitted That Met QC Criteria: November 4, 2008
• First Posted (Estimate): November 5, 2008

Study Record Updates

• Last Update Posted (Estimate): August 25, 2009
• Last Update Submitted That Met QC Criteria: August 21, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: LACAC_L_04305