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

Not Applicable

Recruiting

• Conditions: Photoaging
• Interventions: Device: radiofrequency microneedling combined with 1927 nm thulium laser; Device: radiofrequency microneedling monotherapy

• Registration Number: NCT06029725
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-08
• Study Start: 2023-12-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Primary Completion: 2024-12-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RFMN+Thulium	radiofrequency microneedling combined with 1927 nm thulium laser	-
RFMN	radiofrequency microneedling monotherapy	-

Primary Outcome Measures

Name	Time	Method
Change in wrinkles	6 months after last treatment session	software-assisted evaluation of wrinkles (Vectra(R) Software, Canfield)
Change in pigmentation	6 months after last treatment session	software-assisted evaluation of pigmentation (Vectra(R) Software, Canfield)
Change in volume	6 months after last treatment session	software-assisted evaluation of volume (Vectra(R) Software, Canfield)

Secondary Outcome Measures

Name	Time	Method
Adverse Events	before every treatment session, at every follow-up visit (3 and 6 months post-treatment)	number of adverse events (AE)
Pain intensity	10 minutes after starting each treatment session, one treatment session takes 30-50 minutes	pain intensity (numeric rating scale) during treatment
Withdrawals due to AE	before every treatment session, at every follow-up visit (3 and 6 months post-treatment)	number of withdrawal due to AE

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany