Skin ConditionsPhase 1NCT01467778
Safety Study of Three Formulations of the Dermal Implant ELAPR
A Phase 1 study testing ELAPR in people with Skin Conditions, run by Elastagen Pty Ltd at 1 site in Australia.
Trial summary
This is a Phase I study to assess the safety of three formulations of the dermal implant ELAPR. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Conditions
- What is being tested?
- ELAPR
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2010to May 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good general health status
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
Australia1 site
Woolcock Institute of Medical Research
Glebe, New South Wales, 2037
About this study
Official title: A Phase I Study to Assess the Safety of Three Formulations of the Dermal Implant ELAPR in Healthy Subjects
This is a Phase I study to assess the safety of three formulations of the dermal implant ELAPR.
Read the detailed description
A Phase I study to assess the safety of three formulations of the dermal implant ELAPR in healthy subjects.
- Conditions
- Skin Conditions
- Being tested
- ELAPR
- Keywords
- skin
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELAPRDevice
Also called Other Names:, Tropoelastin 0.1ml SC implant
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.
ELAPRDevice
Also called Tropoelastin 0.1ml SC implant
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
| Study group | Role | What they receive |
|---|---|---|
| ELAPR001 | Active comparator | Tropoelastin 0.1ml SC implant Receives: Device: ELAPR |
| ELAPR002 | Active comparator | Tropoelastin 0.1ml SC implant Receives: Device: ELAPR |
| ELAPR003 | Active comparator | Tropoelastin 0.1ml SC implant Receives: Device: ELAPR |
| Saline | Placebo comparator | Normal Saline 0.9% Receives: Device: ELAPR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (1)
Persistence
To determine implant persistence by histopathology and clinical observation
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startDec 2010
- Primary completionMar 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elastagen Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos China, MBBS, Principal investigator, Woolcock Institute of Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467778
- Sponsor's protocol ID
- ELAPR-P1
- Status last verified
- Nov 2011
- First submitted
- 22 Mar 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess the Safety of Three Formulations of the Dermal Implant ELAPR in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01467778
- Acronym / sponsor ID
- ELAPR-P1
- Conditions
- Skin Conditions
- Keywords
- skin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Elastagen Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ELAPR001 | Active comparator | Device: ELAPRTropoelastin 0.1ml SC implant |
| ELAPR002 | Active comparator | Device: ELAPRTropoelastin 0.1ml SC implant |
| ELAPR003 | Active comparator | Device: ELAPRTropoelastin 0.1ml SC implant |
| Saline | Placebo comparator | Device: ELAPRNormal Saline 0.9% |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Good general health status
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELAPRAlso: Other Names:, Tropoelastin 0.1ml SC implantELAPR 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. | Device | ELAPR001, ELAPR002, ELAPR003, Saline |
| ELAPRAlso: Tropoelastin 0.1ml SC implantImplant 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 | Device | ELAPR001, ELAPR002, ELAPR003, Saline |
Primary outcome
Safety and tolerability measured by the amount of adverse events and serious adverse events
Time frame: 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
1 secondary outcome
Persistence
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos China, MBBS principal investigator
Woolcock Institute of Medical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ELAPR in people with Skin Conditions, run by Elastagen Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability measured by the amount of adverse events and serious adverse events (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2011.