Stretch Mark
Conditions
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.
Interventions
DEVICEVenus 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.
Sponsors
Venus Concept
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Volume of Striae Via Antera 3D Imaging System Analysis From Baseline to 16 Weeks Post-final Treatment | 16 Weeks Post-Final Treatment (Week 28) | 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) | 16 Weeks Post-Final Treatment (Week 28) | 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
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | 16 Weeks Post-Final Treatment (Week 28) | 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 | Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12) | 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 | Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12) | 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. |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Venus Viva |
|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 9.1 |
| Fitzpatrick Skin Type I | 1 Participants |
| Fitzpatrick Skin Type II | 10 Participants |
| Fitzpatrick Skin Type III | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 2 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
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).
Time frame: 16 Weeks Post-Final Treatment (Week 28)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Viva | Overall Stretch Mark Improvement From Baseline to 16 Weeks Post-Final Treatment Assessed by the Global Aesthetic Improvement Scale (GAIS) | 1.7 units on a scale | Standard Error 0.4 |
Primary
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.
Time frame: 16 Weeks Post-Final Treatment (Week 28)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Viva | Percent Change in Volume of Striae Via Antera 3D Imaging System Analysis From Baseline to 16 Weeks Post-final Treatment | -28.3 percentage change from baseline | Standard Error 4.7 |
Secondary
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.
Time frame: 16 Weeks Post-Final Treatment (Week 28)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Viva | Subject Satisfaction | 3.1 units on a scale | Standard Error 0.3 |
Secondary
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.
Time frame: Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Viva | Subject Scale - 5 Point Scale for Treatment Tolerability | 3.1 units on a scale | Standard Error 0.2 |
Secondary
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.
Time frame: Treatment 1 (Week 1), Treatment 2 (Week 4), Treatment 3 (Week 8), Treatment 4 (Week 12)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Venus Viva | Subject Scale - Visual Analog Scale for Pain | 3.8 units on a scale | Standard Error 0.2 |