Safety Study of Three Formulations of the Dermal Implant ELAPR

Elastagen

Status and phase: Completed; Phase 1

Conditions: Skin Conditions

Treatments: Device: ELAPR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01467778

ELAPR-P1

Details and patient eligibility

About

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

Full description

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

Enrollment: 14 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

14 participants in 4 patient groups, including a placebo group

ELAPR001

Active Comparator group

Description:

Tropoelastin 0.1ml SC implant

Treatment:

Device: ELAPR

Device: ELAPR

ELAPR002

Active Comparator group

Description:

Tropoelastin 0.1ml SC implant

Treatment:

Device: ELAPR

Device: ELAPR

ELAPR003

Active Comparator group

Description:

Tropoelastin 0.1ml SC implant

Treatment:

Device: ELAPR

Device: ELAPR

Saline

Placebo Comparator group

Description:

Normal Saline 0.9%

Treatment:

Device: ELAPR

Device: ELAPR