Combination Therapy for Rejuvenation of the Lower Face and Neck

Laxity; Skin Clinical Trial

Official title: Combination Therapy for Rejuvenation of the Lower Face and Neck

Status Not yet recruiting

Clinical Trial Summary

An investigator initiated trial in which 20 subjects with moderate to severe changes of the jawline, neck and décolletage will undergo combination treatment to achieve comprehensive rejuvenation of the jawline and neck.

Clinical Trial Description

Aging changes in the lower face, neck and decollete are complex and involve skin, subcutaneous tissue/SMAS and muscle. It follows therefore that rejuvenation of the jawline, neck and decollettage requires a multifactorial, combination approach. Microfocused Ultrasound (MFU-V, Ultherapy) has been demonstrated to noninvasively lift the skin of the submentum, neck, and reduce wrinkling of the décolletage.1-3 Injection of dilute calcium hydroxylapatite (Radiesse) has also demonstrated improvement of skin quality and reduction of wrinkles in the neck and décolletage skin.4 Combination therapy using MFU-V and Radiesse has been used successfully to improve the appearance of the neck and décolletage and botulinum toxin A has been used to improve jawline contouring and wrinkling of the décolletage.5,6 It is well recognized that skincare products such as MicroFirm Neck and Decollete Rejuvenating Complex improve skin quality and overall skin appearance. Further, Belotero Balance has been demonstrated to have optimal biophysical properties for placement in the superficial dermis and subsequent correction of etched lines.7 It is not surprising that horizontal "necklace lines" in the neck respond better to injection of Belotero Balance than any other reported treatment. Evaluation of the combination of skincare, botulinum toxin, MFU-V, and Radiesse for rejuvenation of the jawline, neck, and décolletage has not been studied.

Proposal: I propose an investigator initiated trial in which 20 subjects with moderate to severe changes of the jawline, neck and décolletage will undergo combination treatment to achieve comprehensive rejuvenation of the jawline and neck. Adequate time will be allowed for follow up to determine the complete effects of all treatments administered.

Materials and Methods: Neocutis MicroFirm Neck and Decollete treatment would be initiated at Day 0 and continued bid throughout the entire duration of the protocol.

Ultherapy will be used to treat the the lower face/neck and décolletage and will also be provided at Day 0. Ultherapy treatments would of course be customized to meet each patient's needs. The general guidelines that would be used to treat the lower face/jawline/neck would be the 4-4.5 transducer (approx. 350 lines) and the 7-3.0 transducer (approx. 460 lines). The décolletage area would be treated with the following transducers: 4-4.5 (approx. 120 lines), 7-3.0 (approx. 120 lines), and 10-1.5 (approx. 40 lines). As per consensus recommendations, Ultherapy will be administered prior to injectables.8 Dilute Radiesse (1:2 with injectable saline and 1% lidocaine without epinephrine) will be injected into the neck and décolletage at days 30, 90, and 150. Radiesse will be injected as per standard protocol using sterile technique and administered via a subcutaneous fanning approach. A total of 3 Radiesse injections will be administered at 8 weeks intervals (Days 30, 90, and 150). The amount of Dilute Radiesse used will be at the discretion of the Investigator but will not exceed 4.5mls for both treatment areas, the neck and décolletage.

Xeomin will be injected in a "Nefertiti Lift" pattern horizontally, parallel to the jawline, vertically in the platysma bands, and extending into the décolletage as indicated based on platysma muscle anatomy. A total dose of no more than 70U of Xeomin will be utilized. The first Xeomin injection will also be administered at Day 30. Additional Xeomin injections will be administered at Day 120. Subjects will be assessed at Day 44 +/- 3 days, and Day 134 +/- 3 days to assess outcomes of Xeomin injections and provide touch up injections if indicated.

Belotero Balance will be injected in horizontal necklace lines if present at Day 30 with reassessment for optional injection Follow up and possible touch up treatment will be offered at Day 44+/- 3 days. ;

Related Conditions & MeSH terms

• Cutis Laxa
• Laxity; Skin

• NCT number: NCT04102670
• Study type: Interventional
• Source: Nashville Centre for Laser and Facial Surgery
• Contact: Amanda Spear, CCRC
• Phone: 6153291110
• Email: amanda@drbiesman.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2019
• Completion date: December 1, 2020