Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Wrinkles

BTL logo

BTL

Status

Completed

Conditions

Wrinkle

Treatments

Device: BTL-785F

Study type

Interventional

Funder types

Industry

Identifiers

NCT05476211
BTL-785_CTBG100

Details and patient eligibility

About

This study will evaluate the clinical safety and the performance of the BTL-785F system for non-invasive treatment of facial wrinkles. The study is a multicenter single-arm, open-label, interventional study. The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete four (4) treatment visits and two follow-up visits.

Enrollment

46 patients

Sex

All

Ages

21 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male or female subjects over 21 years of age seeking treatment for reduction of wrinkles
  • Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
  • Presence of clearly visible wrinkles in the treated areas (forehead, cheeks) when the face is relaxed as deemed appropriate by the Investigator
  • Subjects willing and able to abstain from partaking in any facial treatments other than the study procedure during study participation
  • Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs of their face taken

Exclusion criteria

  • Local bacterial or viral infection in the area to be treated
  • Local acute inflammation in the area to be treated
  • Impaired immune system caused by any immunosuppressive illness, disease or medication
  • Isotretinoin and tretinoin-containing medication use in the past 12 months
  • Skin related autoimmune diseases
  • Radiation therapy and/or chemotherapy
  • Poor healing and unhealed wounds in the treatment area
  • Metal implants
  • Permanent implant in the treated area
  • Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
  • Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment
  • Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
  • History of skin disorders, keloids, abnormal wound healing and dry or fragile skin
  • History of any type of cancer
  • Active collagen diseases
  • Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)1
  • Pregnancy/nursing or IVF procedure
  • History of bleeding coagulopathies, use of anticoagulants
  • Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea
  • Any surgical procedure in the treatment area within the last three months or before complete healing
  • Poorly controlled endocrine disorders, such as diabetes
  • Acute neuralgia and neuropathy
  • Kidney or liver failure
  • Nerve insensitivity (sensitivity disorders) to heat in the treatment area
  • Varicose veins, pronounced edemas1
  • Prior use of dermal fillers, botulinum toxin, lasers, etc. therapies in the treated area that can influence the study results at the investigator discretion
  • Unwillingness/inability to not change their usual cosmetics and especially not to use anti-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period
  • Electroanalgesia without exact diagnosis of pain etiology
  • Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
  • Blood vessels and lymphatic vessels inflammation
  • Any other disease or condition at the investigator discretion that may pose risk to the patient or compromise the study

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

46 participants in 1 patient group

Reduction of wrinkles
Experimental group
Treatment:
Device: BTL-785F

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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