Skin LaxityNCT05355714
High Intensity Ultrasound for the Treatment of Upper Inner Arm Skin Laxity
A study testing Sofwave and Ultherapy in people with Skin Laxity, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity
- What is being tested?
- Sofwave and Ultherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2022to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
- Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active.
- Must be willing to comply with study treatments and complete the entire course of the study
Who cannot join
- Liposuction to bilateral upper arms during the 12-month period prior to study treatment or any time during the course of the study
- Mesotherapy; dermal fillers, biostimulatory injectables; radiofrequency device treatments; microfocused ultrasound device treatments; laser and light-based device treatments; microneedling; cryolipolysis; high intensity focused electromagnetic energy device treatment; or surgery (i.e., brachyplasty) during the 12-month period before study treatment
- Any investigational treatment of skin crepiness/laxity of the upper arms during the 12-month period before the study treatment
- Creams/cosmeceuticals and/or home therapies to prevent or treat skin laxity during the four-week period before study treatment
- Subjects with scarring in the treatment areas
- History of thrombosis, post-thrombosis syndrome, or any vascular disorder of the bilateral upper extremities
Show all 18Show fewer
- Any history of bleeding or coagulation disorders
- Subjects with tattoos or permanent implants in the treatment areas
- Subjects with a significant history or current evidence of a medical, psychological, or other disorder that, in the investigator's opinion, would preclude enrollment into the study
- Subjects with a history of or presence of any skin condition/disease (including but not limited to any visible rash, atopic dermatitis, psoriasis, actinic keratoses, keratinocyte carcinoma, melanoma, etc.) in the treatment area that might interfere with the diagnosis or evaluation of study parameters
- Subjects with an active bacterial, viral, or fungal infection of the treatment areas
- Subjects who spray tanned or used sunless tanners in the treatment areas four (4) weeks prior to study treatment
- History of lidocaine sensitivity deemed by the investigator to preclude the subject from enrolling into the study
- Subjects planning any cosmetic procedure to the treatment areas during the study period, other than the treatment that will be performed by the investigator
- Presence of incompletely healed wound(s) in the treatment area
- Subject who is on an immunosuppressant or has an autoimmune condition
- Female subjects who are pregnant, planning a pregnancy, or breast feeding during the study
- Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cosmetic Laser Dermatology
San Diego, California, 92121
Sherif Mikhail, MD, 858-657-1004, SMikhail@CLDerm.com
Monica Boen, MD
About this study
Official title: A Single Center, Blinded, Split-Body, Randomized Clinical Trial of High Intensity Ultrasound for the Treatment of Upper Inner Arm Skin Laxity
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.
Read the detailed description
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.
- Conditions
- Skin Laxity
- Being tested
- Sofwave, Ultherapy
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SofwaveDevice
High-Frequency Non-Focused Ultrasound Device
UltherapyDevice
Microfocused Ultrasound with Visualization
| Study group | Role | What they receive |
|---|---|---|
| Sofwave | Experimental | Not described Receives: Device: Sofwave |
| Ultherapy | Other | Not described Receives: Device: Ultherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Inner Arm Visual Skin Crepiness and Laxity
Upper Inner Arm Visual Skin Crepiness/Laxity Grading Scale completed by blinded investigator
Measured: 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
Measured: Screening to Three Months Post-Treatment
Upper Arm Circumference
Blinded Investigator Measurement of Point of Maximal Upper Arm Skin Laxity and Circumference
Measured: Screening to One Month Post-Treatment
Upper Arm Circumference
Blinded Investigator Measurement of Point of Maximal Upper Arm Skin Laxity and Circumference
Measured: Screening to Three Months Post-Treatment
Upper Arm Firmness
Blinded Investigator Measurement of Skin Firmness
Measured: Screening to One Month Post-Treatment
Upper Arm Firmness
Blinded Investigator Measurement of Skin Firmness
Measured: Screening to Three Months Post-Treatment
Upper Arm Elasticity
Blinded Investigator Measurement of Skin Elasticity
Measured: Screening to One Month Post-Treatment
Upper Arm Elasticity
Blinded Investigator Measurement of Skin Elasticity
Measured: Screening to Three Months Post-Treatment
Physician Global Aesthetic Improvement Scale (PGAIS)
Assessment of overall change in treatment area by blinded investigator
Measured: One Month Post-Treatment
Physician Global Aesthetic Improvement Scale (PGAIS)
Assessment of overall change in treatment area by blinded investigator
Measured: Three Months Post-Treatment
Secondary outcomes (17)
Subject Global Aesthetic Improvement Scale (SGAIS)
Assessment of overall change in treatment area by subject
Measured: One Month Post-Treatment
Subject Global Aesthetic Improvement Scale (SGAIS)
Assessment of overall change in treatment area by subject
Measured: Three Months Post-Treatment
Subject Satisfaction Questionnaire
Subject degree of satisfaction with results of treatment
Measured: One Month Post-Treatment
Subject Satisfaction Questionnaire
Subject degree of satisfaction with results of treatment
Measured: Three Months Post-Treatment
Subject Pain Score
Subject Assessment of Pain During Treatment
Measured: Day of Treatment
Erythema
Treating Investigator Evaluation of Erythema
Measured: Day of Treatment
Erythema
Treating Investigator Evaluation of Erythema
Measured: One Month Post-Treatment
Erythema
Treating Investigator Evaluation of Erythema
Measured: Three Months Post-Treatment
Edema
Treating Investigator Evaluation of Edema
Measured: Day of Treatment
Edema
Treating Investigator Evaluation of Edema
Measured: One Month Post-Treatment
Edema
Treating Investigator Evaluation of Edema
Measured: Three Months Post-Treatment
Dyspigmentation
Treating Investigator Evaluation of Dyspigmentation
Measured: Day of Treatment
Dyspigmentation
Treating Investigator Evaluation of Dyspigmentation
Measured: One Month Post-Treatment
Dyspigmentation
Treating Investigator Evaluation of Dyspigmentation
Measured: Three Months Post-Treatment
Ulceration
Treating Investigator Evaluation of Ulceration/Erosion
Measured: Day of Treatment
Ulceration
Treating Investigator Evaluation of Ulceration/Erosion
Measured: One Month Post-Treatment
Ulceration
Treating Investigator Evaluation of Ulceration/Erosion
Measured: Three Months Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start14 Apr 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatments will be split-body with subjects receiving treatment from one device on their right side and one on their left.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and Groff
- Sponsor type
- University, hospital or other
- Collaborators
- Sofwave Medical LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355714
- Sponsor's protocol ID
- Sofwave-Ultherapy-2021-12
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Blinded, Split-Body, Randomized Clinical Trial of High Intensity Ultrasound for the Treatment of Upper Inner Arm Skin Laxity
- ClinicalTrials.gov ID
- NCT05355714
- Acronym / sponsor ID
- Sofwave-Ultherapy-2021-12
- Conditions
- Skin Laxity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Goldman, Butterwick, Fitzpatrick and GroffUniversity, hospital or other
- Collaborators
- Sofwave Medical LTD
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Treatments will be split-body with subjects receiving treatment from one device on their right side and one on their left.
| Arm | Type | Receives |
|---|---|---|
| Sofwave | Experimental | Device: Sofwave |
| Ultherapy | Other | Device: Ultherapy |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- A female is considered of childbearing potential unless she is postmenopausal, without a uterus and/or both ovaries, or has had a bilateral tubal ligation.
- Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g., condoms and spermicide), abstinence, and/or vasectomy of partner with a documented second acceptable method of birth control, should the subject become sexually active.
- Must be willing to comply with study treatments and complete the entire course of the study
Key exclusion criteria (18 listed)
- Liposuction to bilateral upper arms during the 12-month period prior to study treatment or any time during the course of the study
- Mesotherapy; dermal fillers, biostimulatory injectables; radiofrequency device treatments; microfocused ultrasound device treatments; laser and light-based device treatments; microneedling; cryolipolysis; high intensity focused electromagnetic energy device treatment; or surgery (i.e., brachyplasty) during the 12-month period before study treatment
- Any investigational treatment of skin crepiness/laxity of the upper arms during the 12-month period before the study treatment
- Creams/cosmeceuticals and/or home therapies to prevent or treat skin laxity during the four-week period before study treatment
- Subjects with scarring in the treatment areas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SofwaveHigh-Frequency Non-Focused Ultrasound Device | Device | Sofwave |
| UltherapyMicrofocused Ultrasound with Visualization | Device | Ultherapy |
Primary outcome
Upper Inner Arm Visual Skin Crepiness and Laxity
Time frame: Screening to One Month Post-Treatment
Upper Inner Arm Visual Skin Crepiness/Laxity Grading Scale completed by blinded investigator
Upper Inner Arm Visual Skin Crepiness and Laxity
Time frame: Screening to Three Months Post-Treatment
Upper Inner Arm Visual Skin Crepiness/Laxity Grading Scale completed by blinded investigator
Upper Arm Circumference
Time frame: Screening to One Month Post-Treatment
Blinded Investigator Measurement of Point of Maximal Upper Arm Skin Laxity and Circumference
Upper Arm Circumference
Time frame: Screening to Three Months Post-Treatment
Blinded Investigator Measurement of Point of Maximal Upper Arm Skin Laxity and Circumference
Upper Arm Firmness
Time frame: Screening to One Month Post-Treatment
Blinded Investigator Measurement of Skin Firmness
Upper Arm Firmness
Time frame: Screening to Three Months Post-Treatment
Blinded Investigator Measurement of Skin Firmness
Upper Arm Elasticity
Time frame: Screening to One Month Post-Treatment
Blinded Investigator Measurement of Skin Elasticity
Upper Arm Elasticity
Time frame: Screening to Three Months Post-Treatment
Blinded Investigator Measurement of Skin Elasticity
Physician Global Aesthetic Improvement Scale (PGAIS)
Time frame: One Month Post-Treatment
Assessment of overall change in treatment area by blinded investigator
Physician Global Aesthetic Improvement Scale (PGAIS)
Time frame: Three Months Post-Treatment
Assessment of overall change in treatment area by blinded investigator
17 secondary outcomes
Subject Global Aesthetic Improvement Scale (SGAIS)
Time frame: One Month Post-Treatment
Subject Global Aesthetic Improvement Scale (SGAIS)
Time frame: Three Months Post-Treatment
Subject Satisfaction Questionnaire
Time frame: One Month Post-Treatment
Subject Satisfaction Questionnaire
Time frame: Three Months Post-Treatment
Subject Pain Score
Time frame: Day of Treatment
Erythema
Time frame: Day of Treatment
Erythema
Time frame: One Month Post-Treatment
Erythema
Time frame: Three Months Post-Treatment
Edema
Time frame: Day of Treatment
Edema
Time frame: One Month Post-Treatment
Edema
Time frame: Three Months Post-Treatment
Dyspigmentation
Time frame: Day of Treatment
Dyspigmentation
Time frame: One Month Post-Treatment
Dyspigmentation
Time frame: Three Months Post-Treatment
Ulceration
Time frame: Day of Treatment
Ulceration
Time frame: One Month Post-Treatment
Ulceration
Time frame: Three Months Post-Treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sofwave and Ultherapy in people with Skin Laxity, run by Goldman, Butterwick, Fitzpatrick and Groff at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea Pacheco (858 657 1004, APacheco@CLDerm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Inner Arm Visual Skin Crepiness and Laxity (time frame: Screening to One Month Post-Treatment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.