Dermacyd PH_DESILSTY_FR (Lactic Acid) - Acceptability - Stay on Frutal

Phase 3

Completed

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

• Registration Number: NCT00932945
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To prove the safety of the gynecological formulation in normal conditions of use.

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: Female
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dermacyd PH_DESILSTY_FR (Lactic Acid)	LACTIC ACID(ND)	Treatment duration: 21 consecutive days

Primary Outcome Measures

Name	Time	Method
Evaluation of the absence of irritation and the good acceptability by using one specific scale which describes the intensity of the reaction.	From the treatment start up to the end of the study (treatment period 21 days)

Trial Locations

Locations (1)

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