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Safety Study of Three Formulations of the Dermal Implant ELAPR | Clinical Trials | Clareo Health

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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

NCT01467778•Elastagen Pty Ltd

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

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

Locations (1)

Woolcock Institute of Medical Research

Glebe, New South Wales, Australia

Key Dates

Start Date

December 1, 2010

Primary Completion Date

March 1, 2011

Completion Date

May 1, 2011

Last Updated

November 9, 2011

Enrollment

ACTUAL participants

Conditions

Skin Conditions

Interventions

ELAPR

DEVICE

ELAPR

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 9, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety Study of Three Formulations of the Dermal Implant ELAPR

Inclusion Criteria

Exclusion Criteria

Clinical Study to Evaluate the Safety and Efficacy of Candela Technology

Evaluation of the Effects on the Skin of Different Materials Used in Orogastric Tube Detection in Premature Babies

The Impact of Pediatric Skin Disorders: The "Big" Study

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