Safety Study of Three Formulations of the Dermal Implant ELAPR
NCT ID: NCT01467778
Last Updated: 2011-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2010-12-31
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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ELAPR001
Tropoelastin 0.1ml SC implant
ELAPR
ELAPR implant product is under development for mid to deep dermal implantation for the treatment of the symptoms of skin aging including the correction of moderate to sever facial wrinkles and folds, such as nasolabial folds and skin abnormalities such as scars.
ELAPR
Implant area of the medial aspect of the upper arm along the posterior line of the bicep is to be selected where there are no pigmentations or moles. Injections will be marked with a tattoo and placed at 2 cm intervals. The order is to be from proximal to distal control, ELAPR001, ELAPR002, ELAPR003
ELAPR002
Tropoelastin 0.1ml SC implant
ELAPR
ELAPR implant product is under development for mid to deep dermal implantation for the treatment of the symptoms of skin aging including the correction of moderate to sever facial wrinkles and folds, such as nasolabial folds and skin abnormalities such as scars.
ELAPR
Implant area of the medial aspect of the upper arm along the posterior line of the bicep is to be selected where there are no pigmentations or moles. Injections will be marked with a tattoo and placed at 2 cm intervals. The order is to be from proximal to distal control, ELAPR001, ELAPR002, ELAPR003
ELAPR003
Tropoelastin 0.1ml SC implant
ELAPR
ELAPR implant product is under development for mid to deep dermal implantation for the treatment of the symptoms of skin aging including the correction of moderate to sever facial wrinkles and folds, such as nasolabial folds and skin abnormalities such as scars.
ELAPR
Implant area of the medial aspect of the upper arm along the posterior line of the bicep is to be selected where there are no pigmentations or moles. Injections will be marked with a tattoo and placed at 2 cm intervals. The order is to be from proximal to distal control, ELAPR001, ELAPR002, ELAPR003
Saline
Normal Saline 0.9%
ELAPR
ELAPR implant product is under development for mid to deep dermal implantation for the treatment of the symptoms of skin aging including the correction of moderate to sever facial wrinkles and folds, such as nasolabial folds and skin abnormalities such as scars.
ELAPR
Implant area of the medial aspect of the upper arm along the posterior line of the bicep is to be selected where there are no pigmentations or moles. Injections will be marked with a tattoo and placed at 2 cm intervals. The order is to be from proximal to distal control, ELAPR001, ELAPR002, ELAPR003
Interventions
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ELAPR
ELAPR implant product is under development for mid to deep dermal implantation for the treatment of the symptoms of skin aging including the correction of moderate to sever facial wrinkles and folds, such as nasolabial folds and skin abnormalities such as scars.
ELAPR
Implant area of the medial aspect of the upper arm along the posterior line of the bicep is to be selected where there are no pigmentations or moles. Injections will be marked with a tattoo and placed at 2 cm intervals. The order is to be from proximal to distal control, ELAPR001, ELAPR002, ELAPR003
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Bleeding diathesis, anticoagulant drugs,thrombocytopenia or clinically significant prolonged APTT or PT
* Chronic use of aspirin, other non-steroidal antiinflammatory drugs or other anti-platelet agents
* History of keloid formation
* Systemic corticosteroids within last 12 weeks
* Diabetes or metabolic disorders
* Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
* Pregnancy/lactation
* A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine
18 Years
70 Years
ALL
Yes
Sponsors
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Elastagen Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Carlos China, MBBS
Role: PRINCIPAL_INVESTIGATOR
Woolcock Institute of Medical Research
Locations
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Woolcock Institute of Medical Research
Glebe, New South Wales, Australia
Countries
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Other Identifiers
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ELAPR-P1
Identifier Type: -
Identifier Source: org_study_id