Dermacyd Delicata Breeze - Photo Evaluation

Phase 3

Completed

• Conditions: Healthy

• Registration Number: NCT00668486
• Lead Sponsor: Sanofi

Brief Summary

The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Breeze.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2008-02
• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-28
• Study First Posted: 2008-04-29
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-09
• Last Update Posted: 2009-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 28

Inclusion Criteria

• Phototype Skin II and III
• Integral skin test in the region

Exclusion Criteria

• Lactation or gestation
• Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection
• Diseases which can cause immunity decrease, such as HIV, diabetes
• Use of drug photosensitizer
• History of sensitivity or irritation for topic products
• Active cutaneous disease which can change the study results
• History or photodermatosis active
• Family or personal antecedent of cutaneous photoinduced neoplasias
• Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium
• Intense solar exposure in the study area
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	5 weeks

Trial Locations

Locations (1)

Sanofi-aventis administrative office; 🇧🇷 São Paulo, Brazil