Sofwave for Laxity; Skin

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cosmetic Laser Dermatology, San Diego, CA
Laxity; Skin+1 More
Sofwave - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Laxity; Skin

Treatment Effectiveness

Study Objectives

5 Primary · 7 Secondary · Reporting Duration: Screening to Three Months Post-Treatment

Day of Treatment
Subject Pain Score
Screening to Three Months Post-Treatment
Upper Arm Circumference
Upper Arm Elasticity
Upper Arm Firmness
Upper Inner Arm Visual Skin Crepiness and Laxity
Three Months Post-Treatment
Dyspigmentation
Edema
Erythema
Physician Global Aesthetic Improvement Scale (PGAIS)
Subject Global Aesthetic Improvement Scale (SGAIS)
Subject Satisfaction Questionnaire
Ulceration

Trial Safety

Trial Design

1 Treatment Group

Sofwave
1 of 1
Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Sofwave · No Placebo Group · N/A

Sofwave
Device
Experimental Group · 1 Intervention: Sofwave · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: screening to three months post-treatment
Closest Location: Cosmetic Laser Dermatology · San Diego, CA
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2016First Recorded Clinical Trial
1 TrialsResearching Laxity; Skin
15 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a female and are of childbearing potential.
You must be willing to comply with study treatments and complete the entire course of the study.
Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants, Implanon®, Depo-Provera®, double-barrier methods (e.g.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.