Safety Study of Three Formulations of the Dermal Implant ELAPR

Study Overview
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Brief Summary
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This is a Phase I study to assess the safety of three formulations of the dermal implant ELAPR.

Detailed Description
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A Phase I study to assess the safety of three formulations of the dermal implant ELAPR in healthy subjects.

Official Title
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A Phase I Study to Assess the Safety of Three Formulations of the Dermal Implant ELAPR in Healthy Subjects

Conditions
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Skin Conditions

Intervention / Treatment
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* Device: ELAPR
* Device: ELAPR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Good general health status 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ELAPR001<br>Tropoelastin 0.1ml SC implant | Device: ELAPR<br>* 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.<br>* Other names: Tropoelastin 0.1ml SC implant;Device: ELAPR<br>* 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<br>* Other names: Tropoelastin 0.1ml SC implant;|
| Active Comparator: ELAPR002<br>Tropoelastin 0.1ml SC implant | Device: ELAPR<br>* 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.<br>* Other names: Tropoelastin 0.1ml SC implant;Device: ELAPR<br>* 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<br>* Other names: Tropoelastin 0.1ml SC implant;|
| Active Comparator: ELAPR003<br>Tropoelastin 0.1ml SC implant | Device: ELAPR<br>* 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.<br>* Other names: Tropoelastin 0.1ml SC implant;Device: ELAPR<br>* 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<br>* Other names: Tropoelastin 0.1ml SC implant;|
| Placebo Comparator: Saline<br>Normal Saline 0.9% | Device: ELAPR<br>* 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.<br>* Other names: Tropoelastin 0.1ml SC implant;Device: ELAPR<br>* 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<br>* Other names: Tropoelastin 0.1ml SC implant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability measured by the amount of adverse events and serious adverse events | To assess the safety and tolerability of a single course of intradermal injections of ELAPR when administered to healthy subjects by reported adverse events and serious adverse events | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistence | To determine implant persistence by histopathology and clinical observation | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin