Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid)- Compatibility

Hygiene Clinical Trial

Official title:

Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINBACK Tangerine Mix.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00784160
• Other study ID #: LACAC_L_04308
• Status: Completed
• Phase: Phase 3
• First received: October 31, 2008
• Last updated: August 21, 2009
• Start date: July 2008
• Est. completion date: September 2008

Study information

• Verified date: August 2009
• 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 PHDETINBACK Tangerine Mix (Lactic Acid).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion criteria:

• Age between 18 and 60 years old;

• 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 gestation;

• Personnel history of atopy;

• History of sensitivity or irritation for topic products;

• Active cutaneous disease;

• Use of new drugs or cosmetics during the study;

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 (Dermacyd PH_DETINBACK Tangerine Mix)
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 dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.		Throughout the study	No