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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: |
NCT01466413 |
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Date of registration:
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18/09/2011 |
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Primary sponsor: |
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Public title:
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Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis
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Scientific title:
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A Phase 1B Study to Assess the Safety and Efficacy of Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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16 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01466413 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
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Countries of recruitment
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Australia
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Contacts
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Name:
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Carlos China, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Woolcock Institute Medical Research |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 35 to 50 years
- Male or Female
- Good general health status
- Able to give informed consent
Exclusion Criteria:
- Clinically significant abnormalities of haematology or biochemistry testing
- Bleeding diathesis
- anticoagulant drugs
- thrombocytopenia or clinically significant prolonged APTT or PT
- Chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other
anti-platelet agents
- History of keloid formation
- Systemic corticosteroids within last 12 weeks
- Diabetes or other metabolic disorders that may interfere with the subject's response
to treatment in the opinion of the investigator
- Any serious medical condition which in the opinion of the investigator would have a
strong possibility of requiring systemic corticosteroid medication
- Pregnancy/lactation
- Previously received Tropoelastin
- A history of anaphylaxis or allergic reactions including any known hypersensitivity
to Hyaluronic acid or lidocaine
- Sensitivity to Restylane® Vital light or Restylane products
- Use of any other investigational product on the intended implant site in the previous
12 months.
- Sensitivity to topical local anaesthetic cream (EMLA®) or have the following
conditions where EMLA is contraindicated: dermatitis, Methaemoglobinaemia,
Glucose-6-phosphate dehydrogenase deficiency or "Mollusca Contagiosa"
Age minimum:
35 Years
Age maximum:
50 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Intrinsic Aging of Skin
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Intervention(s)
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Device: Tropoelastin
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Primary Outcome(s)
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Assess the persistence and tissue compatibility with histopathology.
[Time Frame: 26 weeks]
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Secondary Outcome(s)
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Assess the acute and chronic safety of ELAPR.
[Time Frame: 26 weeks]
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Secondary ID(s)
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ELAPR P1B
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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