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

NCT07225348 | Recruiting Phase 4 FDA Device

• 1 other identifier: SkincarePCH
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Perioral Wrinkles

Keywords

perioral wrinkles; microneedling; poly-L-lactic acid

Outcome Measures

Primary Outcomes (1)

• Global Aesthetic Improvement Scale (GAIS)

  blinded in person GAIS scores

  120 days

Secondary Outcomes (4)

• Lemperle Wrinkle Scale

  120 days

• Lemperle Wrinkle Scale

  120 days

• Canfield VISIA measurements

  120 days

• GAIS

  120 days

Other Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events

  120 days

• Histologic endpoint

  120 days

• Molecular Endpoint

  120 days

Study Arms (2)

Arm A

EXPERIMENTAL

Topical PLLA applied to perioral region first and then a microneedling treatment performed.

Drug: Poly-L-Lactic Acid; Device: Microneedling

Arm B

EXPERIMENTAL

A microneedling treatment is first performed and then topical PLLA is applied.

Drug: Poly-L-Lactic Acid; Device: Microneedling

Interventions

Microneedling DEVICE

Microneedling treatment of the perioral region

Also known as: Eclipse Skin Pen with glide OR MD needle Pen

Arm A; Arm B

Poly-L-Lactic Acid DRUG

Topical PLLA diluted with 8cc of sterile water

Also known as: Sculptra

Arm A; Arm B

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and non-pregnant, non-lactating females 40-70 years of age
• Fitzpatrick Skin Type I-IV
• Wrinkle severity graded by the investigator (1-3 on Lemperle scale)
• Able to provide written informed consent, understand and be willing to comply with all study related procedures and follow-up visits
• Signed informed consent obtained before any study-specific procedure is performed.

You may not qualify if:

• Lesions suspicious for any malignancy, actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the area to be treated
• Tenderness in the treatment rea
• History of keloid formation or hypertrophic scarring
• History of trauma or surgery to the treatment area
• Scar present in the areas to be treated
• Silicone or synthetic material injections in the areas to be treated
• Injection of fat, collagen, hyaluronic acid or other dermal fillers in the areas to be treated within the previous 12 months
• History of treatment with dermabrasion or laser in the areas to be treated within the previous 12 months
• History of treatment with botulinum toxin injections in the areas to be treated within the prior 6 months
• Active smokers (0.5 pack/day) or having quit within 3 months prior treatment
• Active, chronic, or recurrent infection
• History of compromised immune system or currently being treated with immunosuppressive agents
• History of sensitivity to analgesic agents, Aquaphor, topical or local anesthetics
• Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment
• Treatment with fish oil within 14 days prior to treatment

Sponsors & Collaborators

• Skincare Physicians of Chestnut Hill: lead
• Galderma R&D: collaborator

Study Sites (1)

SkinCare Physicians

Chestnut Hill, Massachusetts, 02467, United States

RECRUITING

Related Publications (12)

• 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.

  PMID: 37389474 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.

  PMID: 27419471 BACKGROUND

• Taudorf EH. Laser-assisted delivery of topical methotrexate - in vitro investigations. Dan Med J. 2016 Jun;63(6):B5254.

  PMID: 27264947 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.

  PMID: 23460557 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.

  PMID: 30608292 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.

  PMID: 24852466 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.

  PMID: 15545540 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.

  PMID: 9220727 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.

  PMID: 27257391 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.

  PMID: 15519933 BACKGROUND

MeSH Terms

Interventions

poly(lactide); New-Fill; Percutaneous Collagen Induction

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Punctures; Rehabilitation

Study Officials

• Jessica G Labadie, MD

  SkinCare Physicians

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica G Labadie, MD

CONTACT

6176936125; jlabadie@skincarephysicians.net

Joaninha Barbosa, BS

CONTACT

6177311600; jdepina@skincarephysicians.net

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The results of Part I will directly affect Part II: * If no PLLA is seen in any of the samples from Part I, then we will NOT proceed to the clinical trial in Part II. * If PLLA particles are seen in samples from BOTH protocols, then the clinical trial from part II will proceed as written below. * If PLLA particles are only seen in the samples where the PLLA serum was applied FIRST, then we will DROP Arm B in Part II. * If PLLA particles are only seen in the samples where the PLLA serum was applied second, then we will DROP Arm A in Part II.

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 6, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)