Derm Topics

Injectable Skin Boosters: The Science Behind this New FDA-Approved Injectable Category

At the 2024 ODAC Dermatology, Aesthetic & Surgical Conference, we had the opportunity to learn about injectable skin boosters from Dr. Terrence Keaney, Founder and Director of SkinDC and Clinical Associate Professor of Dermatology at The George Washington University School of Medicine and Health Sciences. In the constantly evolving landscape of aesthetic dermatology, new products and devices are investigated, approved or cleared by the Food and Drug Administration (FDA) of the United States, and brought to market. Reviewing the clinical trial data and his real-world experience over the past 6 months, Dr. Keaney highlighted an injectable category, newly approved by the FDA, with the indication to improve skin quality.

What is a skin booster? What is skin quality?

Although the nomenclature of the overall category needs some tweaking, the FDA-approved skin booster VYC-12L is a low concentration, less crosslinked hyaluronic acid gel for placement into the superficial subcutaneous fat and dermis in the bilateral cheeks. Injected volume ranges from 2-4 mL, with improvement to skin quality expected for about 6 months. Skin quality can encompass a range of visible, topographical, and mechanical characteristics, but Dr. Keaney pinpointed the 3 supported by evidence from the clinical trial: roughness, fine lines, and hydration. To date skin quality treatment options have been limited to chemical peels, microneedling, microdermabrasion, and professional-grade or prescription topicals.

Review of the pivotal clinical trial

In the randomized, multicenter, evaluator-blind phase III clinical trial, cheek smoothness was the primary endpoint, measured by the Allergan Cheek Smoothness Scale. Cheek smoothness significantly improved in the treatment group at 1 month through 6 months.1 Fine lines and skin hydration were secondary outcomes, with a similar timeline of observed benefits. Notably, skin hydration seemed to have sustained, continued improvement even at month 6,1 and Dr. Keaney postulated that this may be due to increased expression of Aquaporin3 by VYC-12L in mechanistic data.2 In the clinical trial, bruising was the most reported adverse event. In a separate retrospective study of about 2000 patients, 1 case of a delayed nodule was reported,3 showing a high level of safety in both clinical trials and “real-world” use when injected by experts.

Practical pearls

Dr. Keaney illustrated the appropriate injection technique, at a 45° angle with 0.01 to 0.05 mL microdroplets spaced 0.5cm to 1 cm apart in a grid pattern on the cheeks. Grid spacing can be narrowed for more injections if increasing the injected volume. He recommended causing a “subtle hill,” rather than a visible bleb, and changing needles frequently to mitigate needle blunting and pain for the patient.

In conclusion, VYC-12L is an FDA-approved injectable hyaluronic acid gel to boost skin quality, specifically roughness, fine lines, and hydration of the cheeks. Although the product is relatively new to market, safety has been demonstrated in clinical trial and retrospective studies. As with other injectables for the face, bruising is the most common risk to discuss with the clinician. From his practice, Dr. Keaney relays high patient satisfaction, with patients endorsing marked improvement in luminosity even though these skin quality attributes may not be captured well by pre- and post-treatment photos.

References

    1. Alexiades M, Palm MD, Kaufman-Janette J, Papel I, Cross SJ, Abrams S, Chawla S. A Randomized, Multicenter, Evaluator-blind Study to Evaluate the Safety and Effectiveness of VYC-12L Treatment for Skin Quality Improvements. Dermatol Surg. 2023 Jul 1;49(7):682-688. PMID: 37163665.
    2. Safa M, Natalizio A, Hee CK. A Prospective, Open-Label Study to Evaluate the Impact of VYC-12L Injection on Skin Quality Attributes in Healthy Volunteers. Clin Cosmet Investig Dermatol. 2022 Mar 10;15:411-426. PMID: 35300433.
    3. Zarbafian M, Beleznay K, Humphrey S. Delayed Adverse Events With VYC-12: A Retrospective Analysis of 2,126 Treatments. Dermatol Surg. 2022 Nov 1;48(11):1261-1262. PMID: 36342258.

This information was presented by Dr. Terrence Keaney during the 2024 ODAC Dermatology, Aesthetic and Surgical Conference. The above highlights from his lecture were written and compiled by Dr. Nagasai Adusumilli. 

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