A Phase 1 interventional study of Hylenex in Dermal Filler, sponsored by Steve Yoelin M.D. Medical Associates, Inc.. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-16.
Sponsored by Steve Yoelin M.D. Medical Associates, Inc. · Phase 1, Interventional, and Treatment
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.
Steve Yoelin M.D. Medical Associates, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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).
Drug: Hylenex
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.
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).
Also known as: Hyaluronidase
Cutaneous Augmentation Grading Scale (Vartanian et al, 2005)
Time frame: 2-6 hours post initial injection
Photography (Volar Aspect) at Site of Injection
Time frame: 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
No study locations are listed for this record.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Steve Yoelin M.D. Medical Associates, Inc.