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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filler | Experimental | 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). |
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| Scale Validation | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hylenex | Drug | 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| Cutaneous Augmentation Grading Scale (Vartanian et al, 2005) | 2-6 hours post initial injection |
| Measure | Description | Time Frame |
|---|---|---|
| Photography (Volar Aspect) at Site of Injection | 1-6 hours post initial injection day 1, day 2 | |
| 3-dimensional (3-D) ultrasound imaging | 1-6 hours post initial injection day 1, day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven G Yoelin, M.D. | Steve Yoelin M.D. Medical Associates, Inc. | Principal Investigator |
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| ID | Term |
|---|---|
| D006821 | Hyaluronoglucosaminidase |
| ID | Term |
|---|---|
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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| D011133 |
| Polysaccharide-Lyases |
| D019757 | Carbon-Oxygen Lyases |
| D008190 | Lyases |