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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: |
NCT00785590 |
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Date of registration:
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04/11/2008 |
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Primary sponsor: |
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Public title:
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Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower - Photo Evaluation.
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Scientific title:
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Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower. |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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26 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00785590 |
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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: Supportive Care
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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 II and III;
- 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
- Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection;
- Diseases which can cause immunity decrease, such as HIV, diabetes;
- Use of drug photosensitizer;
- History of sensitivity or irritation for topic products;
- Active cutaneous disease which can change the study results;
- History of photodermatosis active;
- Family or personal antecedent of cutaneous photoinduced neoplasias;
- Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and
queratoses actinium;
- Intense solar exposure in the study area;
- 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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Female
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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: Dermacyd PH_DETINLYN (Lactic Acid)
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Primary Outcome(s)
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The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale
[Time Frame: Throughout the study]
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The sensibility will be evaluated according to the skin type.
[Time Frame: Throughout the study]
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Secondary ID(s)
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LACAC_L_04300
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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