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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: |
NCT00978887 |
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Date of registration:
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16/09/2009 |
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Primary sponsor: |
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Public title:
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Retorna Facial Cream in the Treatment of Facial Wrinkles
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Scientific title:
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Efficacy of Retorna Facial Cream Usage in the Treatment of Facial Wrinkles |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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148 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00978887 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Cuba
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Contacts
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Name:
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Jose Dominguez Gómez, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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"Commander Manuel Fajardo Rivero" Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Facial wrinkles
- Signed informed consent
- Given verbal agreement on solar exposure prevention within hours of intense solar
radiation (10 am - 4 pm) by the usage of physical protection methods such as
umbrellas, caps and hats.
Exclusion Criteria:
- Pregnancy
- Breast-feeding
- Use of steroids within 6 months.
- Patients under other experimental treatment
- Decompensated concomitant diseases
- Malignant neoplastic conditions.
- Alcoholism
- Handicap and/or psychiatric condition preventing treatment accomplishment.
Age minimum:
20 Years
Age maximum:
60 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Facial Wrinkles
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Intervention(s)
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Other: Placebo
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Other: Retorna
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Primary Outcome(s)
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Total correction or improvement of facial wrinkles at the end of treatment (4 weeks)
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Presence of adverse effects within the 4 week treatment period
[Time Frame: 4 weeks]
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Secondary ID(s)
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CAT-0906-CU
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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