Dermacyd Silver Floral (Lactic Acid) - Compatibility.

Hygiene Clinical Trial

Official title:

Study for Dermatological Evaluation of Topic Compatibility. Primary and Accumulated Dermical Irritability and Dermical Sensitivity for the Product Dermacyd Silver Floral (Lactic Acid).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933712
• Other study ID #: LACAC_L_04839
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2009
• Last updated: September 13, 2010
• Start date: June 2009
• Est. completion date: July 2009

Study information

• Verified date: September 2010
• 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 allergy (sensibilization) of the product Dermacyd Silver Floral

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion criteria:

• Phototype 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 pregnancy

• Use of Antiinflammatory 30 days and/or immunossupression drugs for until 3 months before volunteers selection

• Disease which can cause immunosuppresion, such as diabetes, HIV

• Use of Antihistamines 30 days before selection

• Personnel history of atopy

• History of sensitivity or irritation for topic products

• Cutaneous active disease (local and/or general) which can modify the study results

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

• Cutaneous reaction

• Previous participation in studies using the same product in test

• Volunteer which has immunodeficiency congenital or acquired

• Relevant history or confirmation of alcohol or other drugs abuse

• Intolerance detected or suspected for some component of the sample tested

• Medecin or sponsor employees or their close family.

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: Treatment

Related Conditions & MeSH terms

• Hygiene

Intervention

Drug:
• LACTIC ACID(ND)
Dermacyd Silver Floral (Lactic Acid) sample will be applied like a curative for 6 weeks.

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	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 period 6 weeks)	No