RFMN in Combination With 1927 nm Thulium Laser for Treating Photoaged Skin

RFMN in Combination With 1927 nm Thulium Laser for Treating Photoaged Skin: a Prospective, Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Photoaging
• Intervention / Treatment: Device: radiofrequency microneedling combined with 1927 nm thulium laser; Device: radiofrequency microneedling monotherapy

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: L Nguyen; Phone Number: +49; Email: l.nguyen@uke.de

Study Locations

• Germany
  • Hamburg, Germany, 20251
    • Recruiting
    • University Medical Center Hamburg-Eppendorf
    • Contact: L Nguyen; Phone Number: +49 (0)40-74100; Email: l.nguyen@uke.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Men and women from the age of 30 years
• good general condition, no relevant previous diseases
• Presence of wrinkles, dermatochalasis on the face, pigment spots, which are an indication for RFMN and thulium laser or comparable methods
• Cognitive ability and willingness to give consent (informed consent)
• Be willing and able to attend follow-up visits

Exclusion Criteria:

• Age < 30 years
• Pregnancy or breastfeeding
• Excessive subcutaneous fatty tissue under the cheeks
• Significant scarring of the region to be treated
• open wounds or lesions of the region to be treated
• Severe or cystic facial acne
• Metallic implants in the face or neck region
• Mental illnesses (psychoses, body perception disorders)
• Use of isotretinoin or other retinoids, psychotropic drugs, coumarins or heparins in the last 2 weeks
• Fillers in the region to be treated < 4 weeks prior and during the study period
• Resurfacing (fractional, ablative, nonablative) of the region of interest < 2 months prior and during the study period
• Plastic aesthetic procedures or other surgical procedures < 6 months prior and during the study period
• Tendency to have excessive scarring
• Lack of informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RFMN+Thulium	Device: radiofrequency microneedling combined with 1927 nm thulium laser; session: radiofrequency microneedling + 1927 nm thulium laser; session: 1927 nm thulium laser monotherapy; session: 1927 nm thulium laser monotherapy
Active Comparator: RFMN	Device: radiofrequency microneedling monotherapy; 1 session: radiofrequency microneedling monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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)

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 03-23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No