Treatment of Perioral Wrinkles Using Topical Poly-L-lactic Acid and Microneedling Device
NCT ID: NCT07225348
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
26 participants
INTERVENTIONAL
2025-11-03
2026-10-01
Brief Summary
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* 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
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
* 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.
TREATMENT
SINGLE
Study Groups
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Arm A
Topical PLLA applied to perioral region first and then a microneedling treatment performed.
Poly-L-Lactic Acid
Topical PLLA diluted with 8cc of sterile water
Microneedling
Microneedling treatment of the perioral region
Arm B
A microneedling treatment is first performed and then topical PLLA is applied.
Poly-L-Lactic Acid
Topical PLLA diluted with 8cc of sterile water
Microneedling
Microneedling treatment of the perioral region
Interventions
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Poly-L-Lactic Acid
Topical PLLA diluted with 8cc of sterile water
Microneedling
Microneedling treatment of the perioral region
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* Treatment with aspirin or other blood thinning agents within 14 days prior to treatment
* History or presence of any clinically significant bleeding disorder
* Co-morbid condition hat in the Investigator's opinion could limit ability to participate int eh study or to comply with follow-up requirements
* History of drug and/or alcohol abuse
* Any issue that, at the discretion of the investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to safely undergo study procedures or give informed consent
* Treatment with an investigational device or agent within 30 days before treatment or during the study period
40 Years
70 Years
ALL
No
Sponsors
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Galderma R&D
INDUSTRY
Skincare Physicians of Chestnut Hill
OTHER
Responsible Party
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Jessica Labadie
Principal Investigator
Principal Investigators
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Jessica G Labadie, MD
Role: PRINCIPAL_INVESTIGATOR
SkinCare Physicians
Locations
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SkinCare Physicians
Chestnut Hill, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Joaninha Barbosa, BS
Role: primary
Jessica G Labadie, MD
Role: backup
References
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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.
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.
Taudorf EH. Laser-assisted delivery of topical methotrexate - in vitro investigations. Dan Med J. 2016 Jun;63(6):B5254.
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.
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.
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.
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
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
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.
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.
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.
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.
Other Identifiers
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SkincarePCH
Identifier Type: -
Identifier Source: org_study_id