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NCT04829227 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Sofwave Treatment to Lift Lax Skin

A Phase 3 study of Skin Laxity, sponsored by Sofwave Medical.

Completed
Registry status
Phase 3
Development phase
45
Enrollment target
4
Study locations

NCT04829227: Completed Phase 3 study of Skin Laxity, sponsored by Sofwave Medical.

NCT04829227 is a Phase 3 study of Skin Laxity that has completed, run by Sofwave Medical. The registered enrollment target is 45 participants, below the 186-participant average among 10 other Skin Laxity trials with a reported enrollment target (76% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04829227, a Phase 3 study of Skin Laxity, has completed, sponsored by Sofwave Medical.

COMPLETED
Registry status
Phase 3
Development phase
45 participants
Enrollment target
4
Study locations

Study Summary

Open-label, non-randomized 2 arms prospective, multi-center, self-controlled clinical study with masked evaluation.

Primary Outcome

as assessed by independent masked evaluators of pre and post treatment images.

Conditions Studied

Interventions

  • DEVICE Sofwave

Study Locations (4)

Tennessee

  • The Practice of Brian S. Biesman, MD - Nashville
  • Tennessee Clinical Research Center - Nashville

New Jersey

  • SLSS, a Division of Schweiger Dermatology Group Research Office - Hackensack

Virginia

  • McDaniel Institute of Aging Research - Virginia Beach

Trial Details

FieldValue
Enrollment Target 45 participants
Start Date 2020-01-10
Est. Completion 2021-12-31
Phase Phase 3
Sofwave Medical

12 total trials

What the finished NCT04829227 record still lists

NCT04829227 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 186-participant average among 10 other Skin Laxity trials with a reported enrollment target (76% lower).

The record links to 1 condition, with Skin Laxity appearing as the primary indexed condition, and to 1 intervention - of which Sofwave is the first listed.

NCT04829227 reports a single indexed study location in Tennessee, New Jersey, Virginia.

Frequently Asked Questions

What is clinical trial NCT04829227 about?

NCT04829227 is a clinical study titled "Safety and Efficacy of Sofwave Treatment to Lift Lax Skin". Open-label, non-randomized 2 arms prospective, multi-center, self-controlled clinical study with masked evaluation.

What is the current status of trial NCT04829227?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 45 participants. The study started on 2020-01-10. Estimated completion is 2021-12-31.

What conditions does trial NCT04829227 study?

This clinical trial studies the following conditions: Skin Laxity.

What interventions are being tested in trial NCT04829227?

The interventions under investigation include: Sofwave (DEVICE).

Who is sponsoring clinical trial NCT04829227?

This trial is sponsored by Sofwave Medical, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04829227 being conducted?

This trial has 4 study locations across New Jersey, Tennessee, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Skin Laxity

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04829227's enrollment target sits among peer trials

45 4th of 10 higher than 7 of 10 other Skin Laxity trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Skin Laxity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04829227, the US trial registry maintained by the National Library of Medicine. NCT04829227 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.