Dermacyd Infantile (Lactic Acid)- Compatibility.

Hygiene Clinical Trial

Official title:

Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermic Irritability, Dermic Sensitivity) of Dermacyd Infantile (Lactic Acid).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881374
• Other study ID #: LACAC_L_04679
• Status: Completed
• Phase: Phase 4
• First received: April 10, 2009
• Last updated: April 14, 2009
• Start date: February 2009
• Est. completion date: March 2009

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion criteria:

• Photo type Skin I,II, III e IV

• Integral skin test in the region

• Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion.

Exclusion criteria:

• Lactation or gestation

• Use of Anti-inflammatory 30 days and/or immunosuppressant drugs during 3 months before the selection

• Diseases which can cause immunity decrease, such as HIV, diabetes

• Previous atopy

• History of sensitivity or irritation for topic products

• Active cutaneous diseases which can interfere in the study results

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

• Cutaneous reactivity

• Previous participation in studies, which had used the product

• Volunteers who have immunodeficiency congenital or acquired

• Relevant clinical history or present evidence of alcohol abuse or others drugs

• Non tolerance to some component of the study product.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

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

Related Conditions & MeSH terms

• Hygiene

Intervention

Drug:
• LACTIC ACID(ND)
Dermacyd Infantile (Lactic Acid)

Locations

Country	Name	City	State
Brazil	Sanofi-Aventis Administrative Office	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The absence of primary and accumulated dermic irritability and dermic sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.		During 6 weeks (i.e. treatment period)	No