CompletedNot Applicable

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

Switzerland17 participantsStarted 2019-05-09

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 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)

Timeframe: 16 Weeks Post-Final Treatment (Week 28)

Trial details

NCT IDNCT05097573

SponsorVenus Concept

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-27

Results submitted2023-07-24

View on ClinicalTrials.gov More Stretch Mark trials

Plain-language summary

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

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

Timeframe: 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)

Timeframe: 16 Weeks Post-Final Treatment (Week 28)