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

NCT ID: NCT05097573

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-09
• Study Completion Date: 2021-10-04

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Venus Viva

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.

Group Type: EXPERIMENTAL

Venus Viva

Intervention Type: 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.

Interventions

Venus Viva

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Healthy, male or female subjects, 18-60 years of age who are seeking treatment for their stretch marks

2. Fitzpatrick skin type I-IV

3. Able to read, understand and voluntarily provide written Informed Consent.

4. Able and willing to comply with the treatment/follow-up schedule and requirements.

Exclusion Criteria

1. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).

2. Subjects with any implantable metal device in the treatment area

3. Permanent implant in the treated area, such as metal plates and screws (excluding dental implants), or an injected chemical substance.

4. Current or history of any kind of cancer, or dysplastic nevi in the treated area.

5. Severe concurrent conditions, such as cardiac disorders.

6. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.

7. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only following a prophylactic regime.

8. Poorly controlled endocrine disorders, such as diabetes.

9. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash.

10. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin.

11. History of bleeding coagulopathies, or use of anticoagulants.

12. Use of isotretinoin (Accutane®) or other systemic retinoids limited up to 10mg/day or as per investigators discretion.

13. Treating over tattoo or permanent makeup.

14. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Venus Concept

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Skinpulse Dermatologie

Geneva, , Switzerland

Countries

Switzerland

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

VI0119

Identifier Type: -

Identifier Source: org_study_id