- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00669058
Dermatological Evaluation of Topic Compatibility-Dermacyd Tina Gel Tangerina Mix
January 27, 2009 updated by: Sanofi
Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermical Irritability, Dermical Sensitivity) of Dermacyd Tina Gel Tangerina 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 Tina Gel Tangerina Mix
Study Overview
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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São Paulo, Brazil
- Sanofi-Aventis Administrative Office
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Phototype Skin I,II, III e IV
- Integral skin test in the region
Exclusion Criteria:
- Lactation or gestation
- Use of Antiinflammatory and/or immunosuppression drugs
- Personnel history of atopy
- History of sensitivity or irritation for topic products
- Active cutaneous disease
- Use of new drugs or cosmetics during the study
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The absence of primary and accumulated dermal irritability and dermal sensitivity will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
Time Frame: six weeks
|
six weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jaderson Lima, Sanofi-aventis administrative office Brazil
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
April 23, 2008
First Submitted That Met QC Criteria
April 28, 2008
First Posted (Estimate)
April 29, 2008
Study Record Updates
Last Update Posted (Estimate)
January 29, 2009
Last Update Submitted That Met QC Criteria
January 27, 2009
Last Verified
January 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LACAC_L_03736
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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