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Device for Improving Skin Quality and Texture on the Face and Neck

NCT06645366 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-09-16

No results posted yet for this study

Summary

The goal of this clinical trial is to investigate the effect of the BTL-785F device (with BTL-785-4-4 tip on BTL-785-4 applicator) on the improvement of skin quality and texture on the face and neck in healthy adult volunteers. The main question it aims to answer is:

Whether the BTL-785F device (with BTL-785-4-4 tip on BTL-785-4 applicator) is able to improve skin quality 3 months post-treatment, as assessed by two-dimensional and three-dimensional photographs.

Participants will complete three treatments, and two follow-up visits.

Conditions

  • Wrinkle
  • Pigmentation
  • Skin Laxity
  • Skin Scarring

Interventions

DEVICE

Treatment with BTL-785F

Three (3) treatment sessions will be applied to the subjects' face and neck using the BTL-785F system equipped with the BTL-785-4-4 tip on BTL-785-4 applicator, lasting from 20 to 60 minutes depending on the size of the treated area. Each treatment will be spaced 2 - 6 weeks apart, after the complete healing of scabs.

Sponsors & Collaborators

  • BTL Industries Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-24
Primary Completion
2025-04-29
Completion
2025-04-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06645366 on ClinicalTrials.gov