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

Photoaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029725
• Other study ID #: 03-23
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2024
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: L Nguyen
• Phone: +49
• Email: l.nguyen[@]uke.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: March 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Photoaging

Intervention

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
• radiofrequency microneedling monotherapy
1 session: radiofrequency microneedling monotherapy

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in wrinkles	software-assisted evaluation of wrinkles (Vectra(R) Software, Canfield)	6 months after last treatment session
Primary	Change in volume	software-assisted evaluation of volume (Vectra(R) Software, Canfield)	6 months after last treatment session
Primary	Change in pigmentation	software-assisted evaluation of pigmentation (Vectra(R) Software, Canfield)	6 months after last treatment session
Secondary	Pain intensity	pain intensity (numeric rating scale) during treatment	10 minutes after starting each treatment session, one treatment session takes 30-50 minutes
Secondary	Adverse Events	number of adverse events (AE)	before every treatment session, at every follow-up visit (3 and 6 months post-treatment)
Secondary	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)