High Intensity Ultrasound for the Treatment of Upper Inner Arm Skin Laxity

NCT05355714 | Unknown

• 1 other identifier: Sofwave-Ultherapy-2021-12
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Laxity

Outcome Measures

Primary Outcomes (10)

• 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

  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

Secondary Outcomes (17)

• Subject Global Aesthetic Improvement Scale (SGAIS)

  One Month Post-Treatment

• Subject Global Aesthetic Improvement Scale (SGAIS)

  Three Months Post-Treatment

• Subject Satisfaction Questionnaire

  One Month Post-Treatment

• Subject Satisfaction Questionnaire

  Three Months Post-Treatment

• Subject Pain Score

  Day of Treatment

Study Arms (2)

Sofwave

EXPERIMENTAL

Device: Sofwave

Ultherapy

OTHER

Device: Ultherapy

Interventions

Sofwave DEVICE

High-Frequency Non-Focused Ultrasound Device

Sofwave

Ultherapy DEVICE

Microfocused Ultrasound with Visualization

Ultherapy

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• k) Must be willing to comply with study treatments and complete the entire course of the study

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead
• Sofwave Medical LTD: collaborator

Study Sites (1)

Cosmetic Laser Dermatology

San Diego, California, 92121, United States

RECRUITING

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Andrea Pacheco

CONTACT

858 657 1004; APacheco@CLDerm.com

Sherif Mikhail, MD

CONTACT

858 657 1004; SMikhail@Westderm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Treatments will be split-body with subjects receiving treatment from one device on their right side and one on their left.

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: May 2, 2022
• Study Start: April 14, 2022
• Primary Completion: April 30, 2023
• Study Completion: October 1, 2023
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)