A Randomized, Single-Center, Double-Blinded, Split-Body Clinical Trial of Poly- l -Lactic Acid for the Treatment of Cellulite of the Buttocks and Thighs.

Publisher: Wolters Kluwer Health Country of Publication: United States NLM ID: 9504371 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1524-4725 (Electronic) Linking ISSN: 10760512 NLM ISO Abbreviation: Dermatol Surg Subsets: MEDLINE

Publication: 2021- : [Philadelphia] : Wolters Kluwer Health
Original Publication: New York, NY : Elsevier Science, c1995-

Cellulite*/drug therapy ; Cellulite*/surgery ; Cosmetic Techniques*; Humans ; Female ; Thigh ; Buttocks ; Prospective Studies ; Lactic Acid/adverse effects

Background: More than 90% of women report concerns of cellulite on their skin. Poly- l lactic acid (PLLA-SCA) is a biocompatible, semipermanent, synthetic filler that induces neocollagenesis.
Objective: To investigate the safety and efficacy of PLLA-SCA for the treatment of cellulite of the buttock and thigh regions.
Methods: This was a prospective, single-center, double-blinded, split-body, clinical trial of 20 women with slight to moderate skin laxity of the buttocks and/or thighs contributing to mild-to-moderate cellulite. Each subject's buttocks and thighs were randomized to receive injections with up to 2 vials of PLLA-SCA or the equivalent volume of bacteriostatic water per treatment area. Subjects received at total of 3 treatments 4 weeks apart and were followed for 330 days.
Results: Treatment of the buttocks with PLLA-SCA resulted in significant reduction of depression depth, improvement in the morphological appearance of the skin, improvement in the grade of skin laxity, and overall improvement in cellulite appearance. Treated thighs showed reduction in the depth and number of depressions and an improvement in overall cellulite appearance. No significant procedure side effects were found.
Conclusion: Poly- l lactic acid offers an effective and safe method for treating cellulite of the buttocks and thighs.
(Copyright © 2023 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Davis DS, Boen M, Fabi SG. Cellulite: patient selection and combination treatments for optimal results—a review and our experience. Dermatol Surg 2019;45:1171–84.
Goldman M. Cellulite: a review of current treatments. Cosmetic dermatology-cedar knolls 2002;15:17–32.
Khan MH, Victor F, Rao B, Sadick NS. Treatment of cellulite: part I. pathophysiology. J Am Acad Dermatol 2010;62:361–70.
Fitzgerald R, Vleggaar D. Using poly-L-lactic acid (PLLA) to mimic volume in multiple tissue layers. J Drugs Dermatol JDD 2009;8:s5–14.
Bauer U, Graivier MH. Optimizing injectable poly- l -lactic acid administration for soft tissue augmentation: the rationale for three treatment sessions. Plast Surg 2011;19:22–7.
Narins RS, Baumann L, Brandt FS, Fagien S, et al. A randomized study of the efficacy and safety of injectable poly- l -lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles. J Am Acad Dermatol 2010;62:448–62.
Sickles CK, Nassereddin A, Gross GP. Poly- l -lactic Acid. StatPearls Publishing; 2021. StatPearls [Internet].
Jabbar A, Arruda S, Sadick N. Off face usage of poly- l -lactic acid for body rejuvenation. J Drugs Dermatol JDD 2017;16:489–94.
Haddad A, Menezes A, Guarnieri C, Coimbra D, et al. Recommendations on the use of injectable poly- l -lactic acid for skin laxity in off-face areas. J Drugs Dermatol JDD 2019;18:929–35.
Kollipara R, Hoss E, Boen M, Alhaddad M, Fabi SG. A randomized, split-body, placebo-controlled trial to evaluate the efficacy and safety of poly-l l -lactic acid for the treatment of upper knee skin laxity. Dermatol Surg 2020;46:1623–7.
Bolton J, Fabi S, Peterson JD, Goldman MP. Poly- l -lactic acid for chest rejuvenation: a retrospective study of 28 cases using a 5-point chest wrinkle scale. Cosmet Dermatol 2011;24:278.
Hexsel D, Dal'Forno T, Hexsel C, Rodrigues T. Cellulite Severity Scale. New York, NY,USA: Mosby-Elsevier 360 Park Avenue South; 2007; pp. AB59.
Kaufman-Janette J, Joseph JH, Kaminer MS, Clark J, et al. Collagenase clostridium histolyticum-aaes for the treatment of cellulite in women: results from two phase 3 randomized, placebo-controlled trials. Dermatol Surg 2021;47:649–56.
Stevens WG, Green JB, Layt C, Kaminer MS, et al. Multicenter pivotal study demonstrates safety and efficacy of a new cellulite procedure: 3-month results. Aesthet Surg J 2022;43:97–108.
Mazzuco R, Sadick NS. The use of poly- l -lactic acid in the gluteal area. Dermatol Surg 2016;42:441–3.
Durairaj KK, Devgan L, Lee BS A, Khachatourian BS N, et al. Poly- l -lactic acid for gluteal augmentation found to be safe and effective in retrospective clinical review of 60 patients. Dermatol Surg 2020;46:S46–S53.
Nikolis A, Enright K, Avelar L, Rice S, et al. A prospective, multicenter trial on the efficacy and safety of poly- l -lactic acid for the treatment of contour deformities of the buttock regions. J Drugs Dermatol JDD 2022;21:304–8.
Shridharani SM, Tisch GM, Ebersole TG, Moak TN, Edwartz C. Clinical experience of poly‐ l ‐lactic acid injections for body contouring treatment. J Cosmet Dermatol 2021;20:1655–62.
Lorenc ZP. Techniques for the optimization of facial and nonfacial volumization with injectable poly- l -lactic acid. Aesthet Plast Surg 2012;36:1222–9.
Bohnert K, Dorizas A, Lorenc P, Sadick NS. Randomized, controlled, multicentered, double-blind investigation of injectable Poly- l -Lactic Acid for improving skin quality. Dermatol Surg 2019;45:718–24.

33X04XA5AT (Lactic Acid)

Date Created: 20230224 Date Completed: 20230417 Latest Revision: 20230814

20240628

10.1097/DSS.0000000000003718

36826378