Photoaging
Conditions
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.
Interventions
DEVICEradiofrequency microneedling combined with 1927 nm thulium laser
1. session: radiofrequency microneedling + 1927 nm thulium laser 2. session: 1927 nm thulium laser monotherapy 3. session: 1927 nm thulium laser monotherapy
DEVICEradiofrequency microneedling monotherapy
1 session: radiofrequency microneedling monotherapy
Sponsors
Universitätsklinikum Hamburg-Eppendorf
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in wrinkles | 6 months after last treatment session | software-assisted evaluation of wrinkles (Vectra(R) Software, Canfield) |
| Change in volume | 6 months after last treatment session | software-assisted evaluation of volume (Vectra(R) Software, Canfield) |
| Change in pigmentation | 6 months after last treatment session | software-assisted evaluation of pigmentation (Vectra(R) Software, Canfield) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 10 minutes after starting each treatment session, one treatment session takes 30-50 minutes | pain intensity (numeric rating scale) during treatment |
| Adverse Events | before every treatment session, at every follow-up visit (3 and 6 months post-treatment) | number of adverse events (AE) |
| 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 |
Countries
Germany
Contacts
Primary ContactL Nguyen
Outcome results
None listed