Randomized Trial of Combination Treatment With Sofwave and Sculptra
ConditionSkin Aging
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorMassachusetts General Hospital
About this trial
Evaluation of treatment on the upper arm with Sculptra and Sofwave on the same day versus Sofwave followed by Sculptra 1 month later.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male and female subjects ≥ 40 years old
Able to provide informed consent
Baseline level of upper arm skin flaccidity and volume loss as defined as type III or greater on the Arm Visual Analog Scale (Arm VAS) for aging
Disqualifiers
Prior treatment to the arms with a biostimulatory agent, energy-based device, or skin-tightening device within the past year.
History of dermabrasion or deep peels involving the upper arms within the past year.
History of prior surgery involving the upper arms.
History of prior fat reduction procedures within the upper arms.
Trial design
Design model
Parallel
Treatments tested in this trial
Sofwave
Deviceparallel beam ultrasound on arm
Sculptra
DrugSculptra injection into arm
Treatment groups
13 Participants
are divided into 2 treatment groupsGroup A: Sofwave and Sculptra same dayActive comparator 2 interventions
Group B: Sofwave and Sculptra one month apartActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
GAIS skin laxity
5-graded scale: worse; no change; improved; much improved; or very much improved.
Time frame
From treatment to 3 months after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: