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Characterization of Skin and Facial Fat Pad Thickness Changes Following Microneedling Radiofrequency With and Without Topical Poly-L-Lactic Acid for Facial Rejuvenation

NCT07261527 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether microneedling RF subcutaneous fat pad thickness in the temple, submental, and cheek regions, to determine whether the addition of topical PLLA after microneedling RF alters or preserves subcutaneous fat pad thickness and to assess patient satisfaction and perceived outcomes following microneedling RF ± PLLA treatment.

Conditions

  • Skin Texture

Interventions

DEVICE

microneedling RF treatment

Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart

DEVICE

PLLA

Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by PLLA application after each treatment

DRUG

Sterile Water as control

Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by sterile water application after each treatment

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Ying Chen, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-24
Primary Completion
2027-07-31
Completion
2027-11-30
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 NCT07261527 on ClinicalTrials.gov