NCT05519124

Brief Summary

This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive treatment of facial wrinkles. The study is a multicenter single-arm, open-label, interventional study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

November 3, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
Last Updated

August 31, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

August 25, 2022

Last Update Submit

August 29, 2022

Conditions

Wrinkle

Keywords

wrinkleskin laxity

Outcome Measures

Primary Outcomes (1)

  • Noninvasive Treatment Of Wrinkles

    Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale. Baseline and post-treatment photographs will be evaluated. A statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale should be achieved.

    4 months

Study Arms (1)

BTL-785-7 Treatment

EXPERIMENTAL
Device: BTL-785-7

Interventions

BTL-785-7DEVICE

Treatment with the BTL-785-7 applicator to the BTL-785F system.

BTL-785-7 Treatment

Eligibility Criteria

Age21 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 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 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 have photographs of their face taken

You may not qualify if:

  • 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 medication1
  • 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
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yael Halaas M.D.

New York, New York, 10022, United States

Location

Gentile Facial Plastic Surgery & Aesthetic Laser Center

Youngstown, Ohio, 44512, United States

Location

Related Publications (1)

  • Gentile R, Halaas Y. Novel Approach to Facial Rejuvenation by Treating Cutaneous and Soft Tissue for Wrinkles Reduction: First Experience from Multicenter Clinical Trial. Facial Plast Surg Aesthet Med. 2024 Jan-Feb;26(1):1-6. doi: 10.1089/fpsam.2023.0015. Epub 2023 Jun 28.

    PMID: 37379470DERIVED

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2022

First Posted

August 29, 2022

Study Start

November 3, 2021

Primary Completion

April 30, 2022

Study Completion

June 22, 2022

Last Updated

August 31, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(2)