Clinical trial NCT05097573: Clinical Evaluation of the Efficacy of Fractional Radiofrequency for the Treatment and Reduction of Stretch Marks
Official title: Clinical Evaluation of the Efficacy of Fractional Radiofrequency for the Treatment and Reduction of Stretch Marks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stretch Mark
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
First posted: 2021-10-28
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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)
measure: 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)
Secondary outcomes:
measure: Subject Satisfaction
timeFrame: 16 Weeks Post-Final Treatment (Week 28)
measure: Subject Scale - Visual Analog Scale for Pain
timeFrame: Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12)
measure: Subject Scale - 5 Point Scale for Treatment Tolerability
timeFrame: Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12)
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Skinpulse Dermatologie
Study officials:
References: