Back to resultsClinical Evaluation of the Efficacy of Fractional Radiofrequency for the Treatment and Reduction of Stretch Marks
Primary Purpose
Stretch Mark
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Venus Viva
Sponsored by
About this trial
This is an interventional treatment trial for Stretch Mark
Eligibility Criteria
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.
- 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.
Sites / Locations
- Skinpulse Dermatologie
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Venus Viva
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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).
Secondary Outcome Measures
Subject Satisfaction
Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale at 16 weeks post-treatment. The Subject Satisfaction Scale is a five-grade subjective test.
Participants were asked to rate their satisfaction level with the results. Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied.
Subject Scale - Visual Analog Scale for Pain
Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS). The Visual Analog Scale is a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be). Possible responses were of 0 to 0.4 cm can be considered (no pain); 0.5 to 4.4 cm (mild pain), 4.5 to 7.4 cm (moderate pain), and 7.5 to 10 cm (severe pain). No anaesthetic was used.
An average of all 4 treatments was taken for each subject.
Subject Scale - 5 Point Scale for Treatment Tolerability
Subject's assessment of treatment tolerability as measured by a 5-point scale. Participants were asked about their tolerability level immediately post-treatment. Possible scores were; (4) Very Tolerable, (3) Tolerable, (2) Having No Opinion, (1) Intolerable, and (0) Very Intolerable.
An average of all 4 treatments was taken for each subject.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05097573
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 9, 2019 (Actual)
Primary Completion Date
August 27, 2021 (Actual)
Study Completion Date
October 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venus Concept
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stretch Mark
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Venus Viva
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Venus Viva
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Change in Volume of Striae Via Antera 3D Imaging System Analysis From Baseline to 16 Weeks Post-final Treatment
Description
Change from baseline to the follow-up visit 16 weeks post-final treatment as a percentage of baseline volume.
Time Frame
16 Weeks Post-Final Treatment (Week 28)
Title
Overall Stretch Mark Improvement From Baseline to 16 Weeks Post-Final Treatment Assessed by the Global Aesthetic Improvement Scale (GAIS)
Description
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).
Time Frame
16 Weeks Post-Final Treatment (Week 28)
Secondary Outcome Measure Information:
Title
Subject Satisfaction
Description
Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale at 16 weeks post-treatment. The Subject Satisfaction Scale is a five-grade subjective test.
Participants were asked to rate their satisfaction level with the results. Possible responses were (4) Very Satisfied, (3) Satisfied, (2) Having No Opinion, (1) Unsatisfied, and (0) Very Unsatisfied.
Time Frame
16 Weeks Post-Final Treatment (Week 28)
Title
Subject Scale - Visual Analog Scale for Pain
Description
Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS). The Visual Analog Scale is a scale from 0 cm (no pain) and 10 cm (pain as bad as it can be). Possible responses were of 0 to 0.4 cm can be considered (no pain); 0.5 to 4.4 cm (mild pain), 4.5 to 7.4 cm (moderate pain), and 7.5 to 10 cm (severe pain). No anaesthetic was used.
An average of all 4 treatments was taken for each subject.
Time Frame
Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12)
Title
Subject Scale - 5 Point Scale for Treatment Tolerability
Description
Subject's assessment of treatment tolerability as measured by a 5-point scale. Participants were asked about their tolerability level immediately post-treatment. Possible scores were; (4) Very Tolerable, (3) Tolerable, (2) Having No Opinion, (1) Intolerable, and (0) Very Intolerable.
An average of all 4 treatments was taken for each subject.
Time Frame
Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
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.
Facility Information:
Facility Name
Skinpulse Dermatologie
City
Geneva
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of the Efficacy of Fractional Radiofrequency for the Treatment and Reduction of Stretch Marks
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