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| Name | Class |
|---|---|
| Galderma R&D | INDUSTRY |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Topical PLLA applied to perioral region first and then a microneedling treatment performed. |
|
| Arm B | Experimental | A microneedling treatment is first performed and then topical PLLA is applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poly-L-Lactic Acid | Drug | Topical PLLA diluted with 8cc of sterile water |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Aesthetic Improvement Scale (GAIS) | blinded in person GAIS scores | 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Lemperle Wrinkle Scale | three blinded raters, who will judge scores of pre- and post-treatment photographs using the Lemperle Wrinkle Scale | 120 days |
| Lemperle Wrinkle Scale | treating investigator reported score using the Lemperle Wrinkle Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | the incidence and severity of systemic and cutaneous adverse events | 120 days |
| Histologic endpoint | PLLA particles visualized within MN channels on H&E with polariscopic examination |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica G Labadie, MD | Contact | 6176936125 | 1705 | jlabadie@skincarephysicians.net |
| Joaninha Barbosa, BS | Contact | 6177311600 | 1625 | jdepina@skincarephysicians.net |
| Name | Affiliation | Role |
|---|---|---|
| Jessica G Labadie, MD | SkinCare Physicians | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SkinCare Physicians | Recruiting | Chestnut Hill | Massachusetts | 02467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37389474 | 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. | |
| 27419471 | 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. |
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| ID | Term |
|---|---|
| C033616 | poly(lactide) |
| C482305 | New-Fill |
| D000097244 | Percutaneous Collagen Induction |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D011677 | Punctures |
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The results of Part I will directly affect Part II:
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| Microneedling | Device | Microneedling treatment of the perioral region |
|
|
| 120 days |
| Canfield VISIA measurements | wrinkle severity scores as calculated by the computerized Canfield VISIA measurements | 120 days |
| GAIS | subject and treating investigator reported score using the GAIS | 120 days |
| 120 days |
| Molecular Endpoint | Molecular testing (Gene Markers) | 120 days |
| 27264947 | Background | Taudorf EH. Laser-assisted delivery of topical methotrexate - in vitro investigations. Dan Med J. 2016 Jun;63(6):B5254. |
| 23460557 | 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. |
| 30608292 | 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. |
| 24852466 | 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 |
| 15545540 | 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. |
| 9220727 | 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. |
| 27257391 | 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. |
| 15519933 | 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. |
| D012046 |
| Rehabilitation |