Dermacyd Silver Floral (Lactic Acid) - Compatibility - Stay on Floral

Phase 3

Completed

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

• Registration Number: NCT00933504
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd PHDESILSTYFL.

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: 55

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)	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
Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale	from the treatment start to the end of the study (treatment duration 6 weeks)

Trial Locations

Locations (1)

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