Hyaluronic Acid Filler for Dorsal Finger Volume Loss

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 20
• Participant gender: Both

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Marmur Medical
• Treatments: Hyaluronic Acid; Lidocaine
• Last Updated: 2016-06-03

Criteria

Inclusion Criteria:

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

2. 18 years of age or older at time of consent. May be male or female.

3. Can be of any Fitzpatrick Skin Type (I-VI).

4. 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.

Exclusion Criteria:

1. Children and adolescents (less than 18 years old)

2. Subjects who are not willing or able to prove written consent.

3. Individuals with any significant medical history including skin disorders and eating disorders.

4. Subjects with previous and/or known hypersensitivity to lidocaine, hyaluronic acid, or any of their

preservatives, wasp/bee/hornet stings, and/or hyaluronidase.

5. Subjects on any substances affecting blood coagulation (i.e. aspirin and other non-steroidal anti-

inflammatory drugs, warfarin, vitamin E, heparin).

6. Subjects with known blood coagulopathies.

7. Subjects with a compromise of local blood supply (i.e. recent surgery, severe scarring).

8. Subjects with previous history of rheumatologic or collagen vascular disease.

9. Subjects who have received semi-permanent or temporary filler in the fingers in the past 18

months.

10. Subjects with any history of permanent filler in the fingers.

11. Subjects with dorsal finger volume loss too severe to be treated in one treatment session.

12. Female patients who are planning a pregnancy, currently pregnant or nursing.

13. Failure to sign photographic consent forms.