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The appearance of the aging skin is influenced by different factors including by the reduced elasticity and increased laxity of the skin, the decreasing volume as well as pigmentation disorders and dilated vascular markings. Currently, there are different methods available to treat the aging skin. Here, the combined treatment of radiofrequency micro needling (RFMN) and thulium laser has been commonly used in clinical practice.
The aim of this clinical study is to investigate the efficacy, patient satisfaction, safety of RFMN and thulium laser treatment in patients with facial, age-related skin laxity, wrinkles, and pigmented lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RFMN+Thulium | Active Comparator |
| |
| RFMN | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiofrequency microneedling combined with 1927 nm thulium laser | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in wrinkles | software-assisted evaluation of wrinkles (Vectra(R) Software, Canfield) | 6 months after last treatment session |
| Change in volume | software-assisted evaluation of volume (Vectra(R) Software, Canfield) | 6 months after last treatment session |
| Change in pigmentation | software-assisted evaluation of pigmentation (Vectra(R) Software, Canfield) | 6 months after last treatment session |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | pain intensity (numeric rating scale) during treatment | 10 minutes after starting each treatment session, one treatment session takes 30-50 minutes |
| Adverse Events | number of adverse events (AE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| L Nguyen | Contact | +49 | l.nguyen@uke.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Recruiting | Hamburg | 20251 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11132125 | Background | Berneburg M, Plettenberg H, Krutmann J. Photoaging of human skin. Photodermatol Photoimmunol Photomed. 2000 Dec;16(6):239-44. doi: 10.1034/j.1600-0781.2000.160601.x. | |
| 21315951 | Background | el-Domyati M, el-Ammawi TS, Medhat W, Moawad O, Brennan D, Mahoney MG, Uitto J. Radiofrequency facial rejuvenation: evidence-based effect. J Am Acad Dermatol. 2011 Mar;64(3):524-35. doi: 10.1016/j.jaad.2010.06.045. |
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| radiofrequency microneedling monotherapy | Device | 1 session: radiofrequency microneedling monotherapy |
|
| before every treatment session, at every follow-up visit (3 and 6 months post-treatment) |
| Withdrawals due to AE | number of withdrawal due to AE | before every treatment session, at every follow-up visit (3 and 6 months post-treatment) |
| 14967794 | Background | Zelickson BD, Kist D, Bernstein E, Brown DB, Ksenzenko S, Burns J, Kilmer S, Mehregan D, Pope K. Histological and ultrastructural evaluation of the effects of a radiofrequency-based nonablative dermal remodeling device: a pilot study. Arch Dermatol. 2004 Feb;140(2):204-9. doi: 10.1001/archderm.140.2.204. |
| 36449871 | Background | Nguyen L, Blessmann M, Schneider SW, Herberger K. Radiofrequency Microneedling for Skin Tightening of the Lower Face, Jawline, and Neck Region. Dermatol Surg. 2022 Dec 1;48(12):1299-1305. doi: 10.1097/DSS.0000000000003607. Epub 2022 Sep 29. |
| 33174686 | Background | Wang JV, Christman MP, Feng H, Ferzli G, Jeon H, Geronemus RG. Laser-assisted delivery of tranexamic acid for melasma: Pilot study using a novel 1927 nm fractional thulium fiber laser. J Cosmet Dermatol. 2021 Jan;20(1):105-109. doi: 10.1111/jocd.13817. Epub 2020 Nov 11. |
| 34826022 | Background | Lu K, Cai S. Efficacy and safety comparison between 1927 nm thulium laser and 2940 nm Er:YAG laser in the treatment of facial atrophic acne scarring: a prospective, simultaneous spilt-face clinical trial. Lasers Med Sci. 2022 Apr;37(3):2025-2031. doi: 10.1007/s10103-021-03465-0. Epub 2021 Nov 26. |
| 30019970 | Background | Serra M, Bohnert K, Sadick N. A randomized, single-blind, study evaluating a 755-nm picosecond pulsed Alexandrite laser vs. a non-ablative 1927-nm fractionated thulium laser for the treatment of facial photopigmentation and aging. J Cosmet Laser Ther. 2018 Oct;20(6):335-340. doi: 10.1080/14764172.2018.1493513. Epub 2018 Jul 18. |
| 35050945 | Background | Friedman PM, Dover JS, Chapas A, Rahman Z, Ross EV, Kilmer SL, Roberts WE, Sodha P, Stimmel JB, Moncrief MBC, Waibel JS. 1,550 nm Erbium-Doped and 1,927 nm Thulium Nonablative Fractional Laser System: Best Practices and Treatment Setting Recommendations. Dermatol Surg. 2022 Feb 1;48(2):195-200. doi: 10.1097/DSS.0000000000003321. |
| 41566557 | Derived | Nguyen L, Blessmann M, Schneider SW, Herberger K. Radiofrequency Microneedling With 1927 nm Thulium Laser Versus Radiofrequency Microneedling Monotherapy for Rejuvenation of Photoaged Skin. J Cosmet Dermatol. 2026 Jan;25(1):e70685. doi: 10.1111/jocd.70685. |