AgingPhase 1/2NCT01463657
Split-face Comparison Study to Assess ELAPR Compared to Juvéderm® for the Treatment of Nasolabial Folds
A Phase 1/2 study testing Juvéderm® Ultra Plus and ELAPR002 in people with Aging, run by Elastagen Pty Ltd at 2 sites in Australia.
Trial summary
Patients presenting to the clinic for treatment of moderate to severe Nasolabial folds will be recruited to receive either ELAPR002b or ELAPR002d for the treatment of one Nasolabial fold and Juvéderm® Ultra Plus for the treatment of the second, opposite Nasolabial fold. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Aging
- What is being tested?
- Juvéderm® Ultra Plus and ELAPR002
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesAustralia
- Study dates
- Nov 2011to Dec 2012
- Phase
- Phase 1/2
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 25 - 65 years
- Male or Female
- Moderate to severe NLFs scored equally as a 3 or 4 out of 5 on both sides of the face using the WAS scale
- Good general health status
- Able to give informed consent
Who cannot join
- Clinically significant abnormalities of haematology or biochemistry testing
- Bleeding diathesis, anticoagulant drugs, thrombocytopenia or clinically significant prolonged bleeding time
- Chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other anti-platelet agents
- Allergy to local anaesthetics
- Active infection at the treatment site
- Treatment of either NLF other than with a hyaluronic acid (HA) dermal filler and treatment with a HA dermal filler within 18 months of enrolment
Show all 14Show fewer
- Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
- Pregnancy/lactation
- History of keloid formation
- Systemic corticosteroids within last 12 weeks
- Diabetes or metabolic disorders
- A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine
- Sensitivity to Juvéderm® Ultra Plus or Juvéderm® products.
- Participation in any other clinical trial one month prior to treatment and for the duration of the study.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Dermatology Institute of Victoria
Melbourne, Victoria, 3141
Cosmedic
Southport, Queensland, 4215
About this study
Official title: A Phase 2 Bilateral (Split-face) Comparison Study to Assess Two Formulations of ELAPR Compared to Juvéderm® Ultra Plus for the Treatment of Moderate to Severe Nasolabial Folds
Patients presenting to the clinic for treatment of moderate to severe Nasolabial folds will be recruited to receive either ELAPR002b or ELAPR002d for the treatment of one Nasolabial fold and Juvéderm® Ultra Plus for the treatment of the second, opposite Nasolabial fold.
Read the detailed description
The treatment will be repeated on Day 29 (if required) and Day 57 (if required) to achieve optimum cosmetic results (OCR).
Each treatment will consist of up to 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each Nasolabial fold using a 27G needle.
Each patient will receive the same preparation implanted as a bolus of 0.1mL at Day 1 into the mid-deep dermis of the skin of the medial aspect of the upper arm using a 27G needle, and two 2mm biopsies will be taken at the same visit on Day 57, Day 85 or Day 169 depending on randomisation for histopathology assessment.
- Conditions
- Aging
- Being tested
- Juvéderm® Ultra Plus, ELAPR002
- Keywords
- Aging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juvéderm® Ultra PlusDevice
Patients will receive either ELAPR002b or ELAPR002d for the treatment of one NLF, and Juvéderm® Ultra Plus for the treatment of the second, opposite NLF. Treatments will be provided on Day 1 and repeated on Day 29 (if required at the discretion of the investigator) Day 57 (if required at the discretion of the investigator)to achieve OCR.
ELAPR002Device
Also called Tropelastin
Each treatment will consist of up 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each NLF using a 27G needle. The needle will be inserted at an approximate angle of 30o parallel to the skin, and the product may be injected by a retrograde injection or by deposition of a bolus. ELAPR and the control may be implanted parallel or perpendicular to the NLF. Exactly the same technique will be used for the treatment of both NLFs for each patient.
| Study group | Role | What they receive |
|---|---|---|
| ELAPR002 | Experimental | Each treatment will consist of up 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each NLF using a 27G needle. The needle will be inserted at an approximate angle of 30o parallel to the skin, and the product may be injected by a retrograde injection or by deposition of a bolus. ELAPR and the control may be implanted parallel or perpendicular to the NLF. Exactly the same technique will be used for the treatment of both NLFs for each patient. Receives: Device: ELAPR002 |
| Juvéderm® Ultra Plus | Active comparator | Each treatment will consist of up 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each NLF using a 27G needle. The needle will be inserted at an approximate angle of 30o parallel to the skin, and the product may be injected by a retrograde injection or by deposition of a bolus. ELAPR and the control may be implanted parallel or perpendicular to the NLF. Exactly the same technique will be used for the treatment of both NLFs for each patient. Receives: Device: Juvéderm® Ultra Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the effect of two formulations of ELAPR on change from baseline of the severity of the Nasolabial folds against a Wrinkle Assessment Scale of Nasolabial folds score at 24 weeks vs. active control
The primary efficacy variable is the change in Wrinkle Assessment Scale (WAS). The values for WAS recorded at each visit will be summarized by treatment.
Measured: 24 weeks
Secondary outcomes (2)
Assess the acute safety of ELAPR
Adverse event profile will be collected.
Measured: 24 weeks
Assess chronic safety of ELAPR
A serum sample will be collected at Day 1, 29, 85, and Day 169, or at the completion visit in the event of early withdrawal or early termination and stored for a maximum of 5 years for the development of an assay to measure circulating anti-tropoelastin antibody levels.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elastagen Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Greg Goodman, MBBS FRACS, Principal investigator, Dermatology Institute of Victoria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463657
- Sponsor's protocol ID
- ELAPR P2
- Status last verified
- Jan 2013
- First submitted
- 18 Sep 2011
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Bilateral (Split-face) Comparison Study to Assess Two Formulations of ELAPR Compared to Juvéderm® Ultra Plus for the Treatment of Moderate to Severe Nasolabial Folds
- ClinicalTrials.gov ID
- NCT01463657
- Acronym / sponsor ID
- ELAPR P2
- Conditions
- Aging
- Keywords
- Aging
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Elastagen Pty LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 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.
Patients presenting to the clinic for treatment of moderate to severe Nasolabial folds will be recruited to receive either ELAPR002b or ELAPR002d for the treatment of one Nasolabial fold and Juvéderm® Ultra Plus for the treatment of the second, opposite Nasolabial fold.
Detailed description
The treatment will be repeated on Day 29 (if required) and Day 57 (if required) to achieve optimum cosmetic results (OCR).
Each treatment will consist of up to 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each Nasolabial fold using a 27G needle.
Each patient will receive the same preparation implanted as a bolus of 0.1mL at Day 1 into the mid-deep dermis of the skin of the medial aspect of the upper arm using a 27G needle, and two 2mm biopsies will be taken at the same visit on Day 57, Day 85 or Day 169 depending on randomisation for histopathology assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELAPR002 | Experimental | Device: ELAPR002Each treatment will consist of up 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each NLF using a 27G needle. The needle will be inserted at an approximate angle of 30o parallel to the skin, and the product may be injected by a retrograde injection or by deposition of a bolus. ELAPR and the control may be implanted parallel or perpendicular to the NLF. Exactly the same technique will be used for the treatment of both NLFs for each patient. |
| Juvéderm® Ultra Plus | Active comparator | Device: Juvéderm® Ultra PlusEach treatment will consist of up 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each NLF using a 27G needle. The needle will be inserted at an approximate angle of 30o parallel to the skin, and the product may be injected by a retrograde injection or by deposition of a bolus. ELAPR and the control may be implanted parallel or perpendicular to the NLF. Exactly the same technique will be used for the treatment of both NLFs for each patient. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 25 - 65 years
- Male or Female
- Moderate to severe NLFs scored equally as a 3 or 4 out of 5 on both sides of the face using the WAS scale
- Good general health status
- Able to give informed consent
Key exclusion criteria (14 listed)
- Clinically significant abnormalities of haematology or biochemistry testing
- Bleeding diathesis, anticoagulant drugs, thrombocytopenia or clinically significant prolonged bleeding time
- Chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other anti-platelet agents
- Allergy to local anaesthetics
- Active infection at the treatment site
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 |
|---|---|---|
| Juvéderm® Ultra PlusPatients will receive either ELAPR002b or ELAPR002d for the treatment of one NLF, and Juvéderm® Ultra Plus for the treatment of the second, opposite NLF. Treatments will be provided on Day 1 and repeated on Day 29 (if required at the discretion of the investigator) Day 57 (if required at the discretion of the investigator)to achieve OCR. | Device | Juvéderm® Ultra Plus |
| ELAPR002Also: TropelastinEach treatment will consist of up 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each NLF using a 27G needle. The needle will be inserted at an approximate angle of 30o parallel to the skin, and the product may be injected by a retrograde injection or by deposition of a bolus. ELAPR and the control may be implanted parallel or perpendicular to the NLF. Exactly the same technique will be used for the treatment of both NLFs for each patient. | Device | ELAPR002 |
Primary outcome
Assess the effect of two formulations of ELAPR on change from baseline of the severity of the Nasolabial folds against a Wrinkle Assessment Scale of Nasolabial folds score at 24 weeks vs. active control
Time frame: 24 weeks
The primary efficacy variable is the change in Wrinkle Assessment Scale (WAS). The values for WAS recorded at each visit will be summarized by treatment.
2 secondary outcomes
Assess the acute safety of ELAPR
Time frame: 24 weeks
Assess chronic safety of ELAPR
Time frame: 24 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 24 Jan 2013.
Related trials for Aging
Recruiting
Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation
Skin Aging
Active, not recruiting
Iterative Design Trial to Assess Dietary Supplements and Other Aging-targeted Therapies
Aging, Longevity
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Not yet recruitingObservational study
Biological Aging Following Full-Arch Implant-Supported Fixed Rehabilitation in Edentulous Patients
Edentulism, Biological Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
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.
Greg Goodman, MBBS FRACS principal investigator
Dermatology Institute of Victoria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Juvéderm® Ultra Plus and ELAPR002 in people with Aging, run by Elastagen Pty Ltd at 2 sites 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 5 inclusion and 14 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 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Assess the effect of two formulations of ELAPR on change from baseline of the severity of the Nasolabial folds against a Wrinkle Assessment Scale of Nasolabial folds score at 24 weeks vs. active control (time frame: 24 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 24 Jan 2013.