## Protocol Section
### Identification Module
**NCT ID:** NCT05524779

**Brief Title:** BTL-785F Device for Non-invasive Reduction of Wrinkles and Overall Facial Improvement

**Official Title:** Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Wrinkles and Overall Improvement of Appearance of the Face

#### Organization Study ID Info
**ID:** BTL-785_CTUS1300
#### Organization
**Class:** INDUSTRY
**Full Name:** BTL Industries Ltd.
### Status Module
#### Completion Date
**Date:** 2023-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-09-06

**Type:** ACTUAL

**Last Update Submit Date:** 2022-09-01

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2023-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-09

**Type:** ESTIMATED

**Status Verified Date:** 2022-09

#### Study First Post Date
**Date:** 2022-09-01
**Type:** ACTUAL
**Study First Submit Date:** 2022-08-30
**Study First Submit QC Date:** 2022-08-30
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** BTL Industries Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**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.

**Detailed Description:** 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.

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 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.

### Conditions Module

**Conditions:**

- Wrinkle

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Treatment of wrinkles with the BTL-785-7 applicator to the BTL-785F system.

**Intervention Names:**

- Device: BTL-785-7

**Label:** BTL-785-7 Treatment

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- BTL-785-7 Treatment

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

**Name:** BTL-785-7

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Noninvasive Treatment Of Wrinkles

**Time Frame:** 5 months

#### Secondary Outcomes

**Description:** Three evaluators will evaluate facial appearance according to the Global Aesthetic Improvement Scale (GAIS) using the photographs taken at the baseline, last therapy visit and both follow-up visits. Each evaluator will be asked to assign a score to a set of photographs. Facial appearance improvement to GAIS is considered when there is an increase in score of the scale. The baseline and post-treatment scores will be compared. If applicable, the statistical significance of obtained results will be analyzed in Microsoft Excel spreadsheet software. The level of significance (α) will be set as 5%.

**Measure:** Skin Quality Assessment

**Time Frame:** 5 months

**Description:** The 5-point Likert scale Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. Pain sensation will be rated by the subjects from 0 (no pain) to 10 (worst possible pain).

**Measure:** Therapy Comfort

**Time Frame:** 5 months

**Description:** The Subject Satisfaction questionnaire will be used for evaluating the satisfaction. The Subject Satisfaction Questionnaire will be given to subjects after the last treatment, at 1-month and 3-month follow-up. The answers to the questions related to the subjects' overall skin and face appearance will vary from "strongly agree" to "strongly disagree".

**Measure:** Subject Satisfaction

**Time Frame:** 5 months

### Eligibility Module

**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 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

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
* Application in the area of chest, heart or over the eyes
* Serious psychopathological disorders (such as schizophrenia)
* Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
* Blood vessels and lymphatic vessels inflammation

**Healthy Volunteers:** True

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Gilbert

**Country:** United States

**Facility:** Contour Medical

**State:** Arizona

**Zip:** 85297

**Location 2:**

**City:** San Marcos

**Contacts:**

***Contact 1:***

- **Email:** dr.holden@holdentimelessbeauty.com

- **Name:** Amanda Holden, MD

- **Phone:** 760-338-0796

- **Role:** CONTACT

***Contact 2:***

- **Name:** Amanda Holden, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Holden Timeless Beauty

**State:** California

**Zip:** 92069

**Location 3:**

**City:** Davie

**Contacts:**

***Contact 1:***

- **Email:** lclmd@precisionskininstitute.com

- **Name:** Lesley Clark-Loeser, MD

- **Phone:** 954-998-0345

- **Role:** CONTACT

***Contact 2:***

- **Name:** Lesley Clark-Loeser, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Precision Skin Institute

**State:** Florida

**Zip:** 33328

**Location 4:**

**City:** Macon

**Contacts:**

***Contact 1:***

- **Email:** DEKent@dsspc.com

- **Name:** David Kent, MD

- **Phone:** 478-742-2180

- **Role:** CONTACT

***Contact 2:***

- **Name:** David Kent, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Skin Care Physicians of Georgia

**State:** Georgia

**Zip:** 31217

**Location 5:**

**City:** New York

**Contacts:**

***Contact 1:***

- **Email:** info@drjenniferlevine.com

- **Name:** Jennifer Levine, MD

- **Phone:** 646-362-5245

- **Role:** CONTACT

***Contact 2:***

- **Name:** Jennifer Levine, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Jennifer Levine MD

**State:** New York

**Zip:** 10075

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M21089

- Name: Facies

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
