BTL-785F Device for Non-invasive Facial Rejuvenation in Patients Injected With Botulinum Toxin

NCT ID: NCT05524766

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-06
• Study Completion Date: 2023-02-08

Brief Summary

This study will evaluate the clinical safety and the efficacy of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive facial treatment in patients injected with botulinum toxin. The aim is to investigate the improvement of overall facial appearance and muscle tone.

Detailed Description

This study is a single-site, open-label, interventional study. The subjects will be enrolled and assigned into two experimental study arms (active and control group).

At the baseline visit health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed.

The treatment administration phase (only for the active group) consists of four (4) treatment visits, delivered 5-10 days apart.

Safety measures will include documentation of adverse events (AE) including the subject's experience of pain or discomfort after the procedure. Occurrence of AE's will be checked immediately after the first treatment visit, prior/post to the every other procedure and at the follow-ups.

Subjects will undergo two follow-up visits scheduled at 1 month and 3 months after the final treatment (the control group will not receive any treatment).

Conditions

Wrinkle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BTL-785-7 Treatment

Subjects will be enrolled for an active treatment with BTL-785F device (BTL-785-7 applicator) for improvement of overall facial appearance and muscle tone in patients injected with botulinum toxin.

Group Type: EXPERIMENTAL

BTL-785-7 Treatment

Intervention Type: DEVICE

Treatment with BTL-785F device (BTL-785-7 applicator) for improvement of overall facial appearance and muscle tone in patients injected with botulinum toxin.

Control

Two (2) patients will be enrolled in the control group study and will not receive any treatment. Following the completion of the investigation, the control group patients will be offered the same treatment course as the active group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

BTL-785-7 Treatment

Treatment with BTL-785F device (BTL-785-7 applicator) for improvement of overall facial appearance and muscle tone in patients injected with botulinum toxin.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Healthy male or female subjects over 21 years of age seeking treatment for reduction of wrinkles and overall aesthetic improvement of the face
• Subjects injected with type A botulinum toxin for facial wrinkles improvement in the past month, but no sooner than 1 week
• Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
• 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

• Bacterial or viral infection, acute inflammations
• Impaired immune system
• Isotretinoin in the past 12 months
• Skin related autoimmune diseases
• Radiation therapy and 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
• 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
• Electroanalgesia without exact diagnosis of pain etiology
• Serious psychopathological disorders (such as schizophrenia)
• Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
• Blood vessels and lymphatic vessels inflammation

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

BTL Industries Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Refresh Dermatology

Houston, Texas, United States

Countries

United States

Other Identifiers

BTL-785_CTUS1100

Identifier Type: -

Identifier Source: org_study_id