NCT05987917

Brief Summary

This study will evaluate the clinical efficacy, safety and the performance of the BTL-785-2 applicator of the BTL-785F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
Last Updated

February 2, 2024

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

August 4, 2023

Last Update Submit

February 1, 2024

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (1)

  • Histological examination

    Evaluation of the facial skin tissue to assess the changes related to levels of HA in the biopsies obtained from both treatment groups and control.

    5 months

Secondary Outcomes (4)

  • Subject Satisfaction

    5 months

  • Therapy Comfort

    5 months

  • Evaluation of Wrinkle Severity

    5 months

  • Evaluation of Overall Facial Appearance According to GAIS

    5 months

Study Arms (3)

Group RF+USN

EXPERIMENTAL

Subjects will be enrolled for an active treatment with BTL-785F (BTL-785-2 applicator) delivering radiofrequency (RF) and ultrasound (USN) for non-invasive facial rejuvenation

Device: BTL-785-2

Group RF

EXPERIMENTAL

Subjects will be enrolled for an active treatment with BTL-785F (BTL-785-2 applicator) delivering radiofrequency (RF) only for non-invasive facial rejuvenation

Device: BTL-785-2

Control

EXPERIMENTAL

Control subject will not receive treatment

Other: No Treatment

Interventions

BTL-785-2DEVICE

Treatment with BTL-785 device (BTL-785-2 applicator) for non-invasive facial rejuvenation

Group RFGroup RF+USN
No TreatmentOTHER

The subject who will serve as control will not be treated with the study device.

Control

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy male or female subjects over 21 years of age seeking treatment with non-invasive radiofrequency and ultrasound treatment for facial rejuvenation
  • Subjects should be able to 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 area 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 undergo punch biopsies in the infraauricular area.
  • Agreement to have their photographs taken for the purpose of this clinical investigation.

You may not qualify if:

  • Bacterial or viral infection, acute inflammations
  • Impaired immune system
  • Isotretinoin 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 any type of cancer
  • Active collagen diseases
  • Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
  • Pregnancy/nursing or IVF procedure
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Schweiger Dermatology PC, Reseach Division

Hackensack, New Jersey, 07601, United States

Location

Related Publications (1)

  • Goldberg DJ. A Novel Technology to Boost Natural Production of Hyaluronic Acid in the Skin Tissue: Human Histology Study. J Cosmet Dermatol. 2025 Apr;24(4):e70159. doi: 10.1111/jocd.70159.

    PMID: 40243133DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

January 25, 2021

Primary Completion

January 3, 2022

Study Completion

January 3, 2022

Last Updated

February 2, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)