Safety Study of Three Formulations of the Dermal Implant ELAPR

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01467778

Enrollment

Registered

2011-11-09

Start date

2010-12-31

Completion date

2011-05-31

Last updated

2011-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Conditions

Keywords

skin

Brief summary

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

Detailed description

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

Interventions

DEVICEELAPR

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability measured by the amount of adverse events and serious adverse events	6 weeks	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

Secondary

Measure	Time frame	Description
Persistence	6 weeks	To determine implant persistence by histopathology and clinical observation

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026