Safety and Efficacy of the BTL-754 Device for Laser Skin Resurfacing Treatment of the Face

NCT06158438 | Completed

• 1 other identifier: BTL-754_CTBG100
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the clinical safety and the performance of the BTL-754 device (equipped with the 754-4 applicator) for reduction of facial wrinkles by the means of laser skin resurfacing treatment.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (1)

• Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale

  The primary efficacy outcome measure is a statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale score according to at least 2 out of 3 blinded dermatologists at 3-months follow-up compared to baseline.

  5 months

Study Arms (1)

BTL-754-4 Treatment

EXPERIMENTAL

Treatment with BTL-754 device with the applicator BTL-754-4 for reduction of facial wrinkles.

Device: BTL-754-4 Treatment

Interventions

BTL-754-4 Treatment DEVICE

Treatment with the BTL-754 device with the BTL-754-4 applicator for reduction of facial wrinkles.

BTL-754-4 Treatment

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female subjects over 22 years of age seeking treatment for reduction of wrinkles.
• Presence of clearly visible wrinkles in the treated area when the face is relaxed as deemed appropriate by the Investigator.
• Subjects are willing to have polycarbonate eye shields placed for study treatment.
• 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.
• Subjects are willing to maintain the usual skin care regimen during study participation with the exception when protocol specified ointments, moisturizers, and cleansers are required during the healing stage. Sunblock is required throughout the subject's participation in the study.
• Subjects are willing to abstain from other facial cosmetic procedures during the study; examples include, but are not limited to: laser or chemical resurfacing, dermabrasion, neuromodulator and/or filler injections, aesthetic facial surgery, etc.
• Subjects are willing and able to comply with protocol requirements, including obtaining study-required digital photographs and assessments, post-care instructions, and returning for follow-up visits.
• Women of childbearing potential are required to use birth control measures.

You may not qualify if:

• Intolerance to anesthetic based agents
• Infectious disease
• Connective tissue disease
• Propensity for keloid formations
• Immunocompromised or compromised healing
• Use of long-standing systemic steroids (e.g. Prednisone, Dexamethasone)
• Pregnant, planning to become pregnant, or breast feeding during the study
• Use of isotretinoin (e.g. Accutane, Sotret, Claravis, Amnesteem) within the past year
• Medical condition that may affect wound healing
• Any unstable medical or psychiatric conditions
• Major systemic diseases - e.g. uncontrolled Diabetes mellitus
• Photosensitivity, medications affecting sensitivity to light
• Corticosteroids or injections of the treated area within the last 90 days, long-term corticosteroids use
• Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators)
• Blepharoplasty (in case of eyelid treatment)

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (1)

Center for specialized medical care - Individual dermatological practice Dr. Mariya Genova

Plovdiv, Plovdiv, 4000, Bulgaria

Location

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: November 28, 2023
• First Posted: December 6, 2023
• Study Start: November 16, 2023
• Primary Completion: June 7, 2024
• Study Completion: August 19, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)