Treatment of Perioral Wrinkles Using Topical Poly-L-lactic Acid and Microneedling Device

Summary

The first goal of this clinical trial is to learn if topical application of PLLA in conjunction with a microneedling treatment works to treat perioral wrinkles in adults. The second goal is to see whether the application of topical PLLA is more effective before or after a microneedling treatment. The main questions it aims to answer are: * Is PLLA present within the MN channels from in vivo biopsy samples? * Is it safe to combine topical PLLA and MN in the treatment of perioral wrinkles, as determined by the incidence and severity of adverse events in healthy subjects? * Does overall aesthetic and skin texture improve in combining microneedling with topical PLLA in the treatment of mild to moderate perioral wrinkles? * Is it the treatment of topical PLLA more effective when applied before or after a microneedling treatment. Researchers will compare the application of PLLA before a microneedling treatment to a microneedling treatment with PLLA application after to see which treatment method is more effective. Participants will: \- receive 2 treatments spaced 4-6 weeks apart of topical PLLA and microneedling

Timeline

Start

2025-11-07

Primary completion

2026-06-01

Completion

2026-10-01

Publications

• Background Cervantes J, Chang YF, Dover JS, Hernandez Alvarez A, Chung HJ. Laser-Assisted and Device-Assisted Filler Delivery: A Histologic Evaluation. Dermatol Surg. 2023 Sep 1;49(9):865-870. doi: 10.1097/DSS.0000000000003870. Epub 2023 Jun 23.
• Background Tian T, Luo Y, Jiang T, Dong Y, Yu A, Chen H, Gao X, Li Y. Clinical effect of ablative fractional laser-assisted topical anesthesia on human skin: A randomized pilot study. J Cosmet Laser Ther. 2016 Nov;18(7):409-412. doi: 10.1080/14764172.2016.1197404. Epub 2016 Aug 5.
• Background Taudorf EH. Laser-assisted delivery of topical methotrexate - in vitro investigations. Dan Med J. 2016 Jun;63(6):B5254.
• Background Waibel JS, Wulkan AJ, Shumaker PR. Treatment of hypertrophic scars using laser and laser assisted corticosteroid delivery. Lasers Surg Med. 2013 Mar;45(3):135-40. doi: 10.1002/lsm.22120. Epub 2013 Mar 4.
• Background Ibrahim O, Ionta S, Depina J, Petrell K, Arndt KA, Dover JS. Safety of Laser-Assisted Delivery of Topical Poly-L-Lactic Acid in the Treatment of Upper Lip Rhytides: A Prospective, Rater-Blinded Study. Dermatol Surg. 2019 Jul;45(7):968-974. doi: 10.1097/DSS.0000000000001743.
• Background Rkein A, Ozog D, Waibel JS. Treatment of atrophic scars with fractionated CO2 laser facilitating delivery of topically applied poly-L-lactic acid. Dermatol Surg. 2014 Jun;40(6):624-31. doi: 10.1111/dsu.0000000000000010.
• Background Physicochemical Characteristics and Hydrolytic Degradation of Polylactic Acid Dermal Fillers: A Comparative Study Nikita G. Sedush 1,* , Kirill T. Kalinin 1, Pavel N. Azarkevich 1 and Antonina A. Gorskaya
• Background Courderot-Masuyer C, Robin S, Tauzin H, et al. Evaluation of the behaviour of wrinkles fibroblasts and normal aged fibroblasts in the presence of poly-L-lactic acid. J Cosmet Dermatol Sci Appl 2012;2:20
• Background Orringer JS, Kang S, Johnson TM, Karimipour DJ, Hamilton T, Hammerberg C, Voorhees JJ, Fisher GJ. Connective tissue remodeling induced by carbon dioxide laser resurfacing of photodamaged human skin. Arch Dermatol. 2004 Nov;140(11):1326-32. doi: 10.1001/archderm.140.11.1326.
• Background Branham GH, Thomas JR. Rejuvenation of the skin surface: chemical peel and dermabrasion. Facial Plast Surg. 1996 Apr;12(2):125-33. doi: 10.1055/s-0028-1082404.
• Background Nikolis A, Bernstein S, Kinney B, Scuderi N, Rastogi S, Sampalis JS. A randomized, placebo-controlled, single-blinded, split-faced clinical trial evaluating the efficacy and safety of KLOX-001 gel formulation with KLOX light-emitting diode light on facial rejuvenation. Clin Cosmet Investig Dermatol. 2016 May 13;9:115-25. doi: 10.2147/CCID.S100697. eCollection 2016.
• Background Airan LE, Hruza G. Current lasers in skin resurfacing. Facial Plast Surg Clin North Am. 2005 Feb;13(1):127-39. doi: 10.1016/j.fsc.2004.06.005.

Drugs

Indications

No indication recorded.