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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: |
NCT01115634 |
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Date of registration:
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01/05/2010 |
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Primary sponsor: |
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Public title:
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Autologous Fibroblast Transplantation in Facial Deformities
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Scientific title:
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Autologous Transplantation of Cultured Fibroblast for Facial Contour Deformities |
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Date of first enrolment:
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September 2008 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01115634 |
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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: Safety/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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Iran, Islamic Republic of
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Contacts
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Name:
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Nasser Aghdami, MD., PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Royan Institute |
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Name:
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Saeed Shafiyan, 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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Royan Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Available and willing to attend all follow-up visits.
- Age > 18 years.
- Able and willing to give informed consent.
Exclusion Criteria:
- Known allergy or sensitivity to collagen fillers
- The subject has received a soft tissue augmentation to the area to be treated within
the last 6 months.
- Subject is unwilling to forgo any cosmetic augmentation procedures for the duration
of the study.
- The subject has received autologous fat transfer in the last 6 months.
- Subject is suffering from facial Kaposi's sarcoma.
- The subject has active skin diseases or inflammation on or near the area of injection
- positive HIV, HBV, HCV
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acne Scars
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Deep Wrinkles of the Forehead
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Glabellar Crease
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Nasolabial Folds
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Intervention(s)
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Biological: Fibroblast
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Biological: fibroblast and gel
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Biological: Placebo
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Primary Outcome(s)
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2-point shift in at least one treated area using a standardized 7-point photoguide
[Time Frame: 6 months]
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Secondary ID(s)
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Royan-skin-002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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