Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02793739 |
| Other study ID # |
GALD2016-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2016 |
| Est. completion date |
August 2021 |
Study information
| Verified date |
September 2021 |
| Source |
Marmur Medical |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Fingers are a part of the body that are often subject to increased signs of aging due to
physical use, trauma and exposure to the environment. The FDA's recent approval of a dermal
filler, calcium hydroxylapatite, in hands has led to increased patient demand for hand
fillers which, in turn, has led to the question of rejuvenation of the dorsal fingers. Due to
the different anatomy of the fingers than the dorsal hand plus the new demand to improve the
entire hand plus the finger area, we aim to characterize the best approach. Youthful fingers
are devoid of wrinkles and often have fuller contours thus hiding the "knuckles" (proximal
and distal interphalangeal joints). With aging and loss of subcutaneous tissue volume,
fingers become wrinkled, look more skeletal, almost emaciated, and joints become much more
prominent, all aesthetic features often disliked by patients. By augmenting the volume in the
dorsal fingers, it is possible that the visibility of such bony structures will be decreased,
wrinkles will become smoother, and a more youthful appearance of the fingers will be
restored.
There have been no published reports, to these investigators' knowledge, of the use of
injectable filler into the dorsal fingers for three-dimensional volume correction. The use of
exogenous hyaluronic acid (HA) filler in the fingers would be off-label. Given that HA filler
has been used safely and effectively in many areas of three-dimensional volume restoration
throughout the body, the investigators believe the HA filler may be used to effectively and
safely correct volume loss in the fingers. The investigators hope that this study will
present current, state of the art, never before reported technique, safety, efficacy and
patient satisfaction of HA filler in this region.
Description:
At Marmur Medical, subjects will be recruited and consented prior to any study evaluations or
procedures; if subjects meet the inclusion/exclusion criteria, participants will be enrolled
into this study. Informed consent will clearly say the use of hyaluronic acid filler for the
treatment of dorsal finger volume loss is investigational. Subjects will also be compensated
for their visits (initial and six follow-ups totalling seven visits). Pre and post treatment
photographs will be taken. Subjects will be given lidocaine cream to apply to the area of
injection for temporary numbing effect prior to injection (10-15 minutes). Ice packs will
also be applied to the area temporarily for numbing effect just prior to injection. The
patient's fingers will be injected with 0.5-2.0 mL of hyaluronic acid total at the level of
the sub-dermal plane. The injected filler will be molded as needed to optimize the correction
of the fingers. Syringes used and amount injected into each finger, as well as the total per
hand, will be documented to the 0.1 mL increment (e.g. 3.4 mL). The expected volume needed is
1-2 syringes per subject initially. On Day 14, subjects will return for evaluation and
possible touch-up of injectable hyaluronic acid filler if needed (at the injector's
discretion). The expected volume needed may be 1-2 syringes per subject for touch-up.
The subjects will return for follow-up at all time-points as follows: day 14 (+/- touch-up
hyaluronic acid injection if necessary), 6 weeks, 3/6/9/12 months. The patient and
investigator(s) will assess the volume enhancement in the fingers. Subjects will be asked to
rate their level of satisfaction with the treatment at follow-up visits (Global Satisfaction
Assessment, Natural Look/Feel Scale). In addition, at the initial visit, subjects will be
given a 30 day diary to fill out that will evaluate for symptomology after injection (pain,
bruising, swelling, redness, sensitivity/tenderness, itching, lumps/bump development,
temporary numbness, signs of vascular compromise or other/open comment box). The subject
diary will be collected at the 3 month follow-up visit. Statistical analysis of the data
gathered will be performed by an outside statistician using tests such as Wilcoxian
signed-rank test (for two observations) or Friedman's test (for more than 2 observations)
using STAT, version 13. All adverse events will be recorded at every follow-up visit. These
events include: redness, swelling, tenderness, nodule development under the skin and
restricted range of motion. More serious adverse events include: compartment syndrome,
infection at injection site, Tyndall effect, persistent granulomatous change, injection
necrosis, persistent erythema with edema, and vascular occlusion causing symptoms such as
pain, numbness and necrosis.
