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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00933504 |
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Date of registration:
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03/07/2009 |
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Primary sponsor: |
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Public title:
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Dermacyd Silver Floral (Lactic Acid) - Compatibility - Stay on Floral
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Scientific title:
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Study for Dermatological Evaluation of Topic Compatibility. Primary and Accumulated Dermical Irritability and Dermical Sensitivity for the Product Dermacyd PH_DESILSTY_FL (Lactic Acid). |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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55 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00933504 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Jaderson Lima |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi-Aventis |
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Key inclusion & exclusion criteria
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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 reactive
- 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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hygiene
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Intervention(s)
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Drug: LACTIC ACID(ND)
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Primary Outcome(s)
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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 duration 6 weeks)]
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Secondary ID(s)
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LACAC_L_04804
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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