- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00933946
Dermacyd Silver Frutal (Lactic Acid) - Compatibility.
September 13, 2010 updated by: Sanofi
Study for Dermatological Evaluation of Topic Compatibility Primary and Accumulated Dermical Irritability and Dermical Sensitivity for the Product Dermacyd Silver Frutal (Lactic Acid).
Primary Objective:
To demonstrate the absence of irritation potential (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product Dermacyd Silver Frutal.
Study Overview
Study Type
Interventional
Enrollment (Actual)
55
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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Sao Paulo, Brazil
- Sanofi-Aventis Administrative Office
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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
All
Description
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
- Diseases which can cause immunosuppresion, such as diabetes, HIV
- Personal 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 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: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Dermacyd Silver Frutal (Lactic Acid)
Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative.
Physiologic solution and mineral oil will be also used as a control sample.
|
Dermacyd Silver Frutal (Lactic Acid) sample will be applied like a curative for 21 consecutive days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation of the absence of primary and accumulated dermical irritability and dermical sensitivity by using International Contact Dermatitis Research Group (ICDRG) scale.
Time Frame: from the treatment start to the end of the study (treatment period 6 weeks)
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from the treatment start to the end of the study (treatment period 6 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
June 1, 2009
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
July 3, 2009
First Submitted That Met QC Criteria
July 3, 2009
First Posted (Estimate)
July 7, 2009
Study Record Updates
Last Update Posted (Estimate)
September 14, 2010
Last Update Submitted That Met QC Criteria
September 13, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- LACAC_L_04842
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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