Personal SatisfactionNCT02793739
Hyaluronic Acid Filler for Dorsal Finger Volume Loss
A study testing Hyaluronic acid filler injection in people with Personal Satisfaction, run by Marmur Medical at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Personal Satisfaction
- What is being tested?
- Hyaluronic acid filler injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Aug 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exhibit volume loss and/or increased laxity and wrinkling of the dorsal fingers as determined by the investigator (moderate to severe volume loss).
- 18 years of age or older at time of consent. May be male or female.
- Can be of any Fitzpatrick Skin Type (I-VI).
- Able and willing to give written informed consent and to comply with requirements of this study protocol. The consent form has been standardized in English. For those patients who do not read and understand English, a consent form will be standardized and provided in a language that they read and understand, if possible.
Who cannot join
- Children and adolescents (less than 18 years old)
- Subjects who are not willing or able to prove written consent.
- Individuals with any significant medical history including skin disorders and eating disorders.
- Subjects with previous and/or known hypersensitivity to lidocaine, hyaluronic acid, or any of their
- preservatives, wasp/bee/hornet stings, and/or hyaluronidase.
- Subjects on any substances affecting blood coagulation (i.e. aspirin and other non-steroidal anti-
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- inflammatory drugs, warfarin, vitamin E, heparin).
- Subjects with known blood coagulopathies.
- Subjects with a compromise of local blood supply (i.e. recent surgery, severe scarring).
- Subjects with previous history of rheumatologic or collagen vascular disease.
- Subjects who have received semi-permanent or temporary filler in the fingers in the past 18
- months.
- Subjects with any history of permanent filler in the fingers.
- Subjects with dorsal finger volume loss too severe to be treated in one treatment session.
- Female patients who are planning a pregnancy, currently pregnant or nursing.
- Failure to sign photographic consent forms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Examining the Efficacy of Hyaluronic Acid Filler to Correct Volume Loss in the Dorsal Fingers
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.
Read the detailed 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.
- Conditions
- Personal Satisfaction
- Being tested
- Hyaluronic acid filler injection
- Keywords
- Safety, Efficacy, Longevity
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid filler injectionProcedure or surgery
Hyaluronic acid filler will be injected into the dorsal fingers at day 0 and at day 14 if a touch-up is necessary.
| Study group | Role | What they receive |
|---|---|---|
| 20 subjects | Experimental | 20 subjects will be enrolled to take part in this study and followed for a period of 12 months. Subjects will receive hyaluronic acid filler injection in the dorsal fingers (2-4 syringes) at the initial visit for volume restoration. If warranted, subjects will receive touch-up of hyaluronic acid at day 14 (1-2 syringes). The investigators expect volume restoration to last 9-12 months. Receives: Procedure: Hyaluronic acid filler injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of three-dimensional volume restoration in the dorsal fingers by hyaluronic acid filler using a 5 point volume loss scale
At each study visit, the investigator or sub-investigator will collect data regarding efficacy of volume restoration in the dorsal fingers by assessing qualitative changes in volume of the dorsal fingers.
Measured: Baseline, Day 14, 6 weeks, 3 months, 6 months, 9 months and 12 months
Secondary outcomes (5)
Patient Satisfaction based on the Global Aesthetic Assessment Scale
At each study visit, the participants will fill out surveys regarding global aesthetic improvement (a 7 point scale).
Measured: Day 14, 6 weeks, 3 months, 6 months, 9 months and 12 months
Patient Satisfaction based on the Natural Look/Feel Scale
At each study visit, the participants will fill out surveys regarding natural look/feel of the the product on a 10 point scale.
Measured: Day 14, 6 weeks, 3 months, 6 months, 9 months and 12 months
Patient Satisfaction based on the Subjective Patient Diary
Over the period of 1 month, patients will be documenting subjective pain, tenderness, redness, itching, development of nodules on a scale of 10.
Measured: 1 month
Patients with treatment-related adverse events as reported by patients and confirmed by investigator and/or sub-investigator
At each study visits, the investigator or sub-investigator will collect data regarding adverse events occurring after hyaluronic acid filler injection into the dorsal fingers. If participants have concerns regarding adverse events they are encouraged to call the office and see the investigator and/or sub-investigator immediately to discuss these concerns.
Measured: Baseline, Day 14, 6 weeks, 3 months, 6 months, 9 months and 12 months
Longevity of hyaluronic acid filler in three-dimensional volume restoration of the dorsal fingers
Over a period of 12 months, the investigator, sub-investigator and participants will be filling out a singular survey at each visit that will determine how long volume restoration lasts before effects are mitigated by hyaluronic acid filler dissolution.
Measured: Baseline, Day 14, 6 weeks, 3 months, 6 months, 9 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2021
- Study completionAug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personal SatisfactionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmur Medical
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen Marmur, Marmur Medical
- Investigators
- Ellen Marmur, MD, Principal investigator, Marmur Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793739
- Sponsor's protocol ID
- GALD2016-01
- Status last verified
- Sep 2021
- First submitted
- 19 May 2016
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: The investigators plan to present data at dermatologic meetings and publish in dermatologic journals. The investigators do not plan to presents individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Examining the Efficacy of Hyaluronic Acid Filler to Correct Volume Loss in the Dorsal Fingers
- ClinicalTrials.gov ID
- NCT02793739
- Acronym / sponsor ID
- GALD2016-01
- Conditions
- Personal Satisfaction
- Keywords
- Safety, Efficacy, Longevity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Marmur MedicalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Aug 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 8 Jun 2016 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 subjects | Experimental | Procedure: Hyaluronic acid filler injection20 subjects will be enrolled to take part in this study and followed for a period of 12 months. Subjects will receive hyaluronic acid filler injection in the dorsal fingers (2-4 syringes) at the initial visit for volume restoration. If warranted, subjects will receive touch-up of hyaluronic acid at day 14 (1-2 syringes). The investigators expect volume restoration to last 9-12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Exhibit volume loss and/or increased laxity and wrinkling of the dorsal fingers as determined by the investigator (moderate to severe volume loss).
- 18 years of age or older at time of consent. May be male or female.
- Can be of any Fitzpatrick Skin Type (I-VI).
- Able and willing to give written informed consent and to comply with requirements of this study protocol. The consent form has been standardized in English. For those patients who do not read and understand English, a consent form will be standardized and provided in a language that they read and understand, if possible.
Key exclusion criteria (16 listed)
- Children and adolescents (less than 18 years old)
- Subjects who are not willing or able to prove written consent.
- Individuals with any significant medical history including skin disorders and eating disorders.
- Subjects with previous and/or known hypersensitivity to lidocaine, hyaluronic acid, or any of their
- preservatives, wasp/bee/hornet stings, and/or hyaluronidase.
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 |
|---|---|---|
| Hyaluronic acid filler injectionHyaluronic acid filler will be injected into the dorsal fingers at day 0 and at day 14 if a touch-up is necessary. | Procedure or surgery | 20 subjects |
Primary outcome
Efficacy of three-dimensional volume restoration in the dorsal fingers by hyaluronic acid filler using a 5 point volume loss scale
Time frame: Baseline, Day 14, 6 weeks, 3 months, 6 months, 9 months and 12 months
At each study visit, the investigator or sub-investigator will collect data regarding efficacy of volume restoration in the dorsal fingers by assessing qualitative changes in volume of the dorsal fingers.
5 secondary outcomes
Patient Satisfaction based on the Global Aesthetic Assessment Scale
Time frame: Day 14, 6 weeks, 3 months, 6 months, 9 months and 12 months
Patient Satisfaction based on the Natural Look/Feel Scale
Time frame: Day 14, 6 weeks, 3 months, 6 months, 9 months and 12 months
Patient Satisfaction based on the Subjective Patient Diary
Time frame: 1 month
Patients with treatment-related adverse events as reported by patients and confirmed by investigator and/or sub-investigator
Time frame: Baseline, Day 14, 6 weeks, 3 months, 6 months, 9 months and 12 months
Longevity of hyaluronic acid filler in three-dimensional volume restoration of the dorsal fingers
Time frame: Baseline, Day 14, 6 weeks, 3 months, 6 months, 9 months and 12 months
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 5 Sep 2021.
- Individual participant dataSharing planned: Undecided. The investigators plan to present data at dermatologic meetings and publish in dermatologic journals. The investigators do not plan to presents individual participant data.
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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.
Ellen Marmur, MD principal investigator
Marmur Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid filler injection in people with Personal Satisfaction, run by Marmur Medical at 1 site in United States.
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 4 inclusion and 16 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 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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?
Efficacy of three-dimensional volume restoration in the dorsal fingers by hyaluronic acid filler using a 5 point volume loss scale (time frame: Baseline, Day 14, 6 weeks, 3 months, 6 months, 9 months and 12 months). 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 5 Sep 2021.