Topic Compatibility Dermacyd Wipes - Lactoserum - Hygiene

Hygiene Clinical Trial

Official title:

Safety Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability and Dermical Sensibility) of Dermacyd Wipes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00371852
• Other study ID #: LACTO_L_01811
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2006
• Last updated: May 15, 2008
• Start date: May 2006

Study information

• Verified date: May 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd wipes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Phototypes: I, II, III and IV;

• Integral skin test in the region;

Exclusion Criteria:

• Lactation or gestation

• Use of Anti-inflammatory and/or immune-suppression drugs

• Personnel history of atopy;

• History of sensibilization or irritation for topic products;

• Active cutaneous disease;

• Use of new drugs and/or cosmetics during the study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hygiene

Intervention

Drug:
• lactoserum

Locations

Country	Name	City	State
Brazil	Sanofi-aventis	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score evaluation of the cutaneous reaction, preconized by International Contact Dermatitis Research Group (ICDRG)