- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02654522
The Use of a Recombinant DNA-based Hyaluronidase to Dissolve Fixed Amounts of Hyaluronic Acid Dermal Fillers
May 15, 2017 updated by: Steven Yoelin, Steve Yoelin M.D. Medical Associates, Inc.
The Use of a Recombinant DNA-based Hyaluronidase (RDNAH/ Hylenex Recombinant) to Dissolve Fixed Amounts of a Variety of Popular Hyaluronic Acid (HA) Dermal Fillers in Human Subjects.
The purpose of this study is to determine whether or not Recombinant DNA-based hyaluronidase (RDNAH/Hylenex recombinant), is safe and effective for dissolving hyaluronic acid (HA) dermal fillers.
Study Overview
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female 18 years of age or older
- Able to speak/write in the English language
- Negative Pregnancy Test on Day 1
- Proposed injection site must be free of any active inflammation
Exclusion Criteria:
- Pregnant or breast feeding
- History of keloid formation
- History of allergic reaction to hyaluronic acid dermal fillers, hyaluronidase, or any ingredients of the aforementioned products
- Active, uncontrolled inflammatory condition of any type
- History of allergic reaction to lidocaine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Filler
Each subject will have one product in one forearm and another product in the other.
Products: JUVEDERM Ultra Plus (24 mg/mL of HA) and VOLUMA (20 mg/mL of HA).
Subjects will be randomized as to which forearm will receive which product.
In one forearm, subject will receive four injections of the assigned HA filler (0.2mL).
HA injections will be placed along a line from the wrist to the antecubital fossa.
The initial 0.2mL HA injection will be placed in the deep dermis 5 cm from the wrist and the subsequent three 0.2mL HA injections will be place in 5 cm increments in the deep dermis along the line noted above.
Same process will be used on the contralateral forearm using the other HA filler.1-3
hours post injection, these 8 HA injection sites (4 per forearm) per subject will then receive a randomized amount of Hylenex recombinant (0U, 30U, 60U or 75U).
|
1-3 hours post injection, the 8 HA injection sites (4 per forearm) per subject will then receive a randomized amount of Hylenex recombinant (0U, 30U, 60U or 75U).
Other Names:
|
No Intervention: Scale Validation
One forearm of one of three subjects will be randomized to the scale "control" forearm.
The opposite forearm of this subject as well as the forearms of the two remaining subjects will receive treatment in this study.
The forearm that has been designated as the scale "control" forearm will be injected with VOLUMA in a straight line into the mid-dermis in the following manner: 0.05ml of VOLUMA will be injected 5 cm proximal to the wrist, 0.1ml of VOLUMA will be injected 10 cm proximal to the wrist, 0.15ml of VOLUMA will be injected 15 cm proximal to the wrist and 0.2ml of VOLUMA will be injected 20 cm proximal to the wrist.
The remaining "randomized" forearms (the non-injected forearm from the subject above and the forearms from the two additional subjects) will be injected in a similar fashion to the "control" forearm as noted above; however, the dose at each location will be randomized.
Control subject will receive no Hylenex until after pertinent data is collected for the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cutaneous Augmentation Grading Scale (Vartanian et al, 2005)
Time Frame: 2-6 hours post initial injection
|
2-6 hours post initial injection
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Photography (Volar Aspect) at Site of Injection
Time Frame: 1-6 hours post initial injection day 1, day 2
|
1-6 hours post initial injection day 1, day 2
|
3-dimensional (3-D) ultrasound imaging
Time Frame: 1-6 hours post initial injection day 1, day 2
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1-6 hours post initial injection day 1, day 2
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Steven G Yoelin, M.D., Steve Yoelin M.D. Medical Associates, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
January 11, 2016
First Submitted That Met QC Criteria
January 12, 2016
First Posted (Estimate)
January 13, 2016
Study Record Updates
Last Update Posted (Actual)
May 16, 2017
Last Update Submitted That Met QC Criteria
May 15, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- HH101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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