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| Name | Class |
|---|---|
| Sofwave Medical LTD | INDUSTRY |
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Upper inner arms of enrolled subjects will be randomized to two (2) treatment groups: Sofwave and Ultherapy, with subjects receiving treatment with one device on their right side and the other on their left.
This is a prospective, single-center, blinded, split-body site, randomized, controlled clinical trial. The study will consist of 15 subjects who will be treated with Sofwave® on one upper medial arm and Ultherapy® to the contralateral upper medial arm for treatment of skin laxity.
Upon enrollment and after a thorough review of the inclusion and exclusion criteria as well as obtaining written and informed consent, each subject will be randomized to have either their right upper inner arm or left upper inner arm treated with Sofwave®, and the contralateral arm will be treated with Ultherapy®. The treatment area is defined as the upper inner medial arm (Appendix A). This area, which abuts the axilla, was chosen as the treatment zone because it is primarily composed of skin on superficial fascia without excessive amounts of adipose tissue. Conversely, the posterior arm typically has extra adipose tissue which would confound the study's measurements
At every visit, the subject's medical history and concomitant medications will be reviewed in detail and weight will be recorded. Additionally, at every treatment and follow-up visit, each subject will have standardized, high-resolution digital photographs taken (Appendix D). Prior to the treatment and at all follow-up visits, the blinded investigator will complete the Upper Inner Arm Visual Crepiness/Laxity Grading Scale, Point of Maximal Upper Arm Skin Laxity Diameter and Circumference Measurements, and skin firmness and elasticity measurements using a Cutometer® Dual MPA 580 (Courage+Khazaka electronic GmbH; Köln, Germany).
Subjects may be treated on the same day that they are screened and provide informed consent. If applicable, a urine pregnancy test will be obtained prior to each treatment. Anesthesia will be provided per physician discretion; options include topical anesthetic (23% lidocaine/7% tetracaine) for 1-hour, oral valium, and/or nitrous oxide. Immediately before treatment, the upper arm treatment zones should be mapped and subsequently cleansed with Hibiclens® (chlorhexidine gluconate solution 4%; Mölnlycke Health Care AB; Gothenburg, Sweden). The arm randomized to receive Sofwave® will receive one treatment session during which the treatment area will receive 3-4 passes. The arm randomized to receive Ultherapy® will receive one treatment session during which the treatment area will receive 1 pass with the 4.0 MHz, 4.5-mm-depth transducer and a subsequent pass with the 7.0 MHz, 3.0-mm-depth transducer. Treatment start and end times will be recorded.
After each treatment session and during all follow-up visits, the treating physician will evaluate the subjects for any procedure-related side effects and adverse events. The subjects will rate their pain. At each follow-up visit, a Physician Global Aesthetic Improvement Scale (PGAIS), Subject Global Aesthetic Improvement Scale (SGAIS), and subject satisfaction questionnaire will be completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sofwave | Experimental |
| |
| Ultherapy | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofwave | Device | High-Frequency Non-Focused Ultrasound Device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Upper Inner Arm Visual Skin Crepiness and Laxity | Upper Inner Arm Visual Skin Crepiness/Laxity Grading Scale completed by blinded investigator | Screening to One Month Post-Treatment |
| Upper Inner Arm Visual Skin Crepiness and Laxity | Upper Inner Arm Visual Skin Crepiness/Laxity Grading Scale completed by blinded investigator | Screening to Three Months Post-Treatment |
| Upper Arm Circumference | Blinded Investigator Measurement of Point of Maximal Upper Arm Skin Laxity and Circumference | Screening to One Month Post-Treatment |
| Upper Arm Circumference | Blinded Investigator Measurement of Point of Maximal Upper Arm Skin Laxity and Circumference | Screening to Three Months Post-Treatment |
| Upper Arm Firmness | Blinded Investigator Measurement of Skin Firmness | Screening to One Month Post-Treatment |
| Upper Arm Firmness | Blinded Investigator Measurement of Skin Firmness | Screening to Three Months Post-Treatment |
| Upper Arm Elasticity | Blinded Investigator Measurement of Skin Elasticity | Screening to One Month Post-Treatment |
| Upper Arm Elasticity |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Global Aesthetic Improvement Scale (SGAIS) | Assessment of overall change in treatment area by subject | One Month Post-Treatment |
| Subject Global Aesthetic Improvement Scale (SGAIS) | Assessment of overall change in treatment area by subject |
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Inclusion Criteria:
a) Male or female subjects > 35 years of age and < 70 years of age b) Subjects in good general health based on investigator's judgment and medical history c) Upper inner arm skin laxity that improves when the skin of the upper inner arm is stretched or lifted superiorly d) Moderate to severe upper inner arm skin crepiness/laxity based on the Upper Inner Arm Visual Crepiness/Laxity Grading Scale (Appendix B) e) Must be willing to give and sign an informed consent form and photographic release form f) Must have a stable body weight for at least six (6) months prior to study entry g) Must be willing to maintain usual sun exposure, diet, and exercise routines for the duration of the study h) Must agree to avoid tanning or use of sunless tanner during the entire course of the study i) Negative urine pregnancy test result at the time of study entry (if applicable) j) For female subjects of childbearing potential, must be willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment.
k) Must be willing to comply with study treatments and complete the entire course of the study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Pacheco | Contact | 858 657 1004 | APacheco@CLDerm.com | |
| Sherif Mikhail, MD | Contact | 858 657 1004 | SMikhail@Westderm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cosmetic Laser Dermatology | Recruiting | San Diego | California | 92121 | United States |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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Treatments will be split-body with subjects receiving treatment from one device on their right side and one on their left.
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| Ultherapy |
| Device |
Microfocused Ultrasound with Visualization |
|
Blinded Investigator Measurement of Skin Elasticity |
| Screening to Three Months Post-Treatment |
| Physician Global Aesthetic Improvement Scale (PGAIS) | Assessment of overall change in treatment area by blinded investigator | One Month Post-Treatment |
| Physician Global Aesthetic Improvement Scale (PGAIS) | Assessment of overall change in treatment area by blinded investigator | Three Months Post-Treatment |
| Three Months Post-Treatment |
| Subject Satisfaction Questionnaire | Subject degree of satisfaction with results of treatment | One Month Post-Treatment |
| Subject Satisfaction Questionnaire | Subject degree of satisfaction with results of treatment | Three Months Post-Treatment |
| Subject Pain Score | Subject Assessment of Pain During Treatment | Day of Treatment |
| Erythema | Treating Investigator Evaluation of Erythema | Day of Treatment |
| Erythema | Treating Investigator Evaluation of Erythema | One Month Post-Treatment |
| Erythema | Treating Investigator Evaluation of Erythema | Three Months Post-Treatment |
| Edema | Treating Investigator Evaluation of Edema | Day of Treatment |
| Edema | Treating Investigator Evaluation of Edema | One Month Post-Treatment |
| Edema | Treating Investigator Evaluation of Edema | Three Months Post-Treatment |
| Dyspigmentation | Treating Investigator Evaluation of Dyspigmentation | Day of Treatment |
| Dyspigmentation | Treating Investigator Evaluation of Dyspigmentation | One Month Post-Treatment |
| Dyspigmentation | Treating Investigator Evaluation of Dyspigmentation | Three Months Post-Treatment |
| Ulceration | Treating Investigator Evaluation of Ulceration/Erosion | Day of Treatment |
| Ulceration | Treating Investigator Evaluation of Ulceration/Erosion | One Month Post-Treatment |
| Ulceration | Treating Investigator Evaluation of Ulceration/Erosion | Three Months Post-Treatment |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |