Dermacyd PH_DESILSTY_FL (Lactic Acid) - Photo Evaluation - Stay on Floral

Phase 3

Completed

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

• Registration Number: NCT00933842
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

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

Secondary Objective:

None.

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 PH_DESILSTY_FL (Lactic Acid)	LACTIC ACID(ND)	Dermacyd PH_DESILSTY_FL (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 to 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 duration 5 weeks)

Trial Locations

Locations (1)

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