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

Study Overview
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Brief Summary
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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.

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

Conditions
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Photoaging

Intervention / Treatment
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* Device: radiofrequency microneedling combined with 1927 nm thulium laser
* Device: radiofrequency microneedling monotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RFMN+Thulium<br> | Device: radiofrequency microneedling combined with 1927 nm thulium laser<br>* session: radiofrequency microneedling + 1927 nm thulium laser session: 1927 nm thulium laser monotherapy session: 1927 nm thulium laser monotherapy<br>|
| Active Comparator: RFMN<br> | Device: radiofrequency microneedling monotherapy<br>* 1 session: radiofrequency microneedling monotherapy<br>|

What is the study measuring?
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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) |