Dermacyd Silver Floral (Lactic Acid) - Photo Evaluation

Phase 3

Completed

• Conditions: Hygiene
• Interventions: Drug: LACTIC ACID(ND)

• Registration Number: NCT00932984
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2009-07-03
• Study First Submitted QC: 2009-07-03
• Study First Posted: 2009-07-07
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-13
• Last Update Posted: 2010-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dermacyd Silver Floral (Lactic Acid)	LACTIC ACID(ND)	Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative. Physiologic solution and mineral oil will be also used as a control sample.

Primary Outcome Measures

Name	Time	Method
Measure of the photo irritation test and the photosensitivity by using UVA irradiation and evaluation according 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)

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇧🇷 Sao Paulo, Brazil