Clinical trial NCT06029725: RFMN in Combination With 1927 nm Thulium Laser for Treating Photoaged Skin
Official title: RFMN in Combination With 1927 nm Thulium Laser for Treating Photoaged Skin: a Prospective, Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Photoaging
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in wrinkles
timeFrame: 6 months after last treatment session
measure: Change in volume
timeFrame: 6 months after last treatment session
measure: Change in pigmentation
timeFrame: 6 months after last treatment session
Secondary outcomes:
measure: Pain intensity
timeFrame: 10 minutes after starting each treatment session, one treatment session takes 30-50 minutes
measure: Adverse Events
timeFrame: before every treatment session, at every follow-up visit (3 and 6 months post-treatment)
measure: Withdrawals due to AE
timeFrame: before every treatment session, at every follow-up visit (3 and 6 months post-treatment)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
References:
citation: 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.
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.
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.
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.
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.
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.
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.
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.