Hyaluronic Acid Filler for Dorsal Finger Volume Loss

NCT02793739 | Completed

• 1 other identifier: GALD2016-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Personal Satisfaction

Keywords

Safety; Efficacy; Longevity

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Day 14, 6 weeks, 3 months, 6 months, 9 months and 12 months

• Patient Satisfaction based on the Natural Look/Feel Scale

  Day 14, 6 weeks, 3 months, 6 months, 9 months and 12 months

• Patient Satisfaction based on the Subjective Patient Diary

  1 month

• Patients with treatment-related adverse events as reported by patients and confirmed by investigator and/or sub-investigator

  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

  Baseline, Day 14, 6 weeks, 3 months, 6 months, 9 months and 12 months

Study Arms (1)

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.

Procedure: Hyaluronic acid filler injection

Interventions

Hyaluronic acid filler injection PROCEDURE

Hyaluronic acid filler will be injected into the dorsal fingers at day 0 and at day 14 if a touch-up is necessary.

20 subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Exhibit volume loss and/or increased laxity and wrinkling of the dorsal fingers as determined by the investigator (moderate to severe volume loss).
• 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.

You may not qualify if:

• 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-
• 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.

Sponsors & Collaborators

• Marmur Medical: lead

Study Sites (1)

Marmur Medical

New York, New York, 10128, United States

Location

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ellen Marmur, MD

  Marmur Medical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Director Marmur Medical, Associate Clinical Professor of Dermatology, Associate Clinical Professor of Genomics and Genetic Science, The Mount Sinai Hospital

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: June 8, 2016
• Study Start: September 1, 2016
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-09

Locations

US (1)