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

NCT06029725 | Recruiting

• 1 other identifier: 03-23
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Photoaging

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Pain intensity

  10 minutes after starting each treatment session, one treatment session takes 30-50 minutes

• Adverse Events

  before every treatment session, at every follow-up visit (3 and 6 months post-treatment)

• Withdrawals due to AE

  before every treatment session, at every follow-up visit (3 and 6 months post-treatment)

Study Arms (2)

RFMN+Thulium

ACTIVE COMPARATOR

Device: radiofrequency microneedling combined with 1927 nm thulium laser

RFMN

ACTIVE COMPARATOR

Device: radiofrequency microneedling monotherapy

Interventions

radiofrequency microneedling combined with 1927 nm thulium laser DEVICE

1. session: radiofrequency microneedling + 1927 nm thulium laser 2. session: 1927 nm thulium laser monotherapy 3. session: 1927 nm thulium laser monotherapy

RFMN+Thulium

radiofrequency microneedling monotherapy DEVICE

1 session: radiofrequency microneedling monotherapy

RFMN

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20251, Germany

RECRUITING

Related Publications (9)

• 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.

  PMID: 11132125 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.

  PMID: 21315951 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.

  PMID: 14967794 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.

  PMID: 36449871 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.

  PMID: 33174686 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.

  PMID: 34826022 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.

  PMID: 30019970 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.

  PMID: 35050945 BACKGROUND

• 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.

  PMID: 41566557 DERIVED

Central Study Contacts

L Nguyen

CONTACT

+49; l.nguyen@uke.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 8, 2023
• Study Start: December 15, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)