Randomized Trial of Combination Treatment With Sofwave and Sculptra

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT07342452
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Skin Aging

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Sofwave — DEVICE
    parallel beam ultrasound on arm
  • Sculptra — DRUG
    Sculptra injection into arm

Study Details

Evaluation of treatment on the upper arm with Sculptra and Sofwave on the same day versus Sofwave followed by Sculptra 1 month later.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
13 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Sofwave and Sculptra same day
  • Active Comparator: Sofwave and Sculptra one month apart

Primary Outcome Measure

GAIS skin laxity [ Time Frame: From treatment to 3 months after treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Molly Wanner, MD
[email protected]
617-643-3885
Margaret Chou, MD
[email protected]
Molly Wanner, MD (PRINCIPAL_INVESTIGATOR)
Margaret Chou, MD (SUB_INVESTIGATOR)
Bridget Myers, MD (SUB_INVESTIGATOR)

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By research site
Massachusetts General Hospital· Boston, MA