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

U

Universitätsklinikum Hamburg-Eppendorf

Status

Enrolling

Conditions

Photoaging

Treatments

Device: radiofrequency microneedling combined with 1927 nm thulium laser
Device: radiofrequency microneedling monotherapy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

35 participants in 2 patient groups

RFMN+Thulium
Active Comparator group
Treatment:
Device: radiofrequency microneedling combined with 1927 nm thulium laser
RFMN
Active Comparator group
Treatment:
Device: radiofrequency microneedling monotherapy

Trial contacts and locations

1

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Central trial contact

L Nguyen

Data sourced from clinicaltrials.gov

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