Dermacyd PH_DETINBACK Tangerine Mix (Lactic Acid)- Compatibility
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)...
Brief Summary
Official Title: “Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd PH_DETINBACK Tangerine Mix.”
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).
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
- Study Primary Completion Date: September 2008
Intervention(s) in this Clinical Trial
- Drug: Lactic Acid (Dermacyd PH_DETINBACK Tangerine Mix)
- Lactic Acid
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Lactic Acid
Outcome Measures for this Clinical Trial
Primary Measures
- The absence of primary and accumulated dermical irritability and dermical sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
- Time Frame: Throughout the study
Safety Issue?: No
- Time Frame: Throughout the study
Criteria for Participation in this Clinical Trial
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;
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 60 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Sanofi-Aventis Industry
Overall Clinical Trial Officials and Contacts
Jaderson Lima Study Director Sanofi-Aventis
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00784160
Study ID Number: LACAC_L_04308
ClinicalTrials.gov Identifier: NCT00784160
Health Authority: Brazil: National Health Surveillance Agency
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00784160
