Clinical Evaluation of the Efficacy of Fractional Radiofrequency for the Treatment and Reduction of Stretch Marks

NCT05097573 | Completed Results FDA Device

• 1 other identifier: VI0119
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single centre, evaluator-blind study of the performance of fractional radiofrequency (RF) for the treatment and revision of stretch marks. The study will evaluate the progress of 15 subjects requesting treatment of stretch marks. The study will involve four treatments on both sides of the face with 4 week intervals between each treatment. Subjects will be followed at 12 and 16 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment.

Conditions

Stretch Mark

Outcome Measures

Primary Outcomes (2)

• Percent Change in Volume of Striae Via Antera 3D Imaging System Analysis From Baseline to 16 Weeks Post-final Treatment

  Change from baseline to the follow-up visit 16 weeks post-final treatment as a percentage of baseline volume.

  16 Weeks Post-Final Treatment (Week 28)

• Overall Stretch Mark Improvement From Baseline to 16 Weeks Post-Final Treatment Assessed by the Global Aesthetic Improvement Scale (GAIS)

  Evaluate the efficacy of overall stretch mark improvement assessed live by the Investigator and a subject assessment of stretch mark including the Global Aesthetic Improvement Scale (GAIS).The Global Aesthetic Improvement Scale is a seven-grade subjective test. The PI evaluated before and after photographs and graded them for change. Possible responses were (3) Very Much Improved, (2) Much Improved, (1) Improved, (0) No Change, (-1) Worse, (-2) Much Worse, and (-3) Very Much Worse. For reporting of outcomes, the higher the GAIS value, the greater the improvement (Range -3 to 3).

  16 Weeks Post-Final Treatment (Week 28)

Secondary Outcomes (3)

• Subject Satisfaction

  16 Weeks Post-Final Treatment (Week 28)

• Subject Scale - Visual Analog Scale for Pain

  Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12)

• Subject Scale - 5 Point Scale for Treatment Tolerability

  Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12)

Study Arms (1)

Venus Viva

EXPERIMENTAL

The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids, stretch marks and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 4 treatments approximately 4 weeks apart.

Device: Venus Viva

Interventions

Venus Viva DEVICE

The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, stretch marks, rhytids and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 4 treatments approximately 4 weeks apart.

Venus Viva

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, male or female subjects, 18-60 years of age who are seeking treatment for their stretch marks
• Fitzpatrick skin type I-IV
• Able to read, understand and voluntarily provide written Informed Consent.
• Able and willing to comply with the treatment/follow-up schedule and requirements.

You may not qualify if:

• Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
• Subjects with any implantable metal device in the treatment area
• Permanent implant in the treated area, such as metal plates and screws (excluding dental implants), or an injected chemical substance.
• Current or history of any kind of cancer, or dysplastic nevi in the treated area.
• Severe concurrent conditions, such as cardiac disorders.
• Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
• History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.
• Poorly controlled endocrine disorders, such as diabetes.
• Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.
• History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.
• History of bleeding coagulopathies, or use of anticoagulants.
• Use of isotretinoin (Accutane®) or other systemic retinoids limited up to 10mg/day or as per investigators discretion.
• Treating over tattoo or permanent makeup.
• Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

Skinpulse Dermatologie

Geneva, Switzerland

Location

MeSH Terms

Conditions

Striae Distensae

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Venus Concept

mgronski@venusconcept.com

888-907-0115

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: October 4, 2021
• First Posted: October 28, 2021
• Study Start: May 9, 2019
• Primary Completion: August 27, 2021
• Study Completion: October 4, 2021
• Last Updated: September 18, 2023
• Results First Posted: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)