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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07261527
Status
Not Yet Recruiting

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Conditions

  • Skin Texture

Eligibility Criteria

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

Interventions

  • microneedling RF treatment — DEVICE
    Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart
  • PLLA — DEVICE
    Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by PLLA application after each treatment
  • Sterile Water as control — DRUG
    Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by sterile water application after each treatment

Study Details

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.

Key Dates

Start date
Nov 24, 2025
Status verified
Nov 2025
Primary completion
Jul 31, 2027
Completion
Nov 30, 2027

Study Design

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

Arms

  • Experimental: microneedling radiofrequency (RF)
  • No Intervention: no treatment
  • Experimental: microneedling RF treatment with topical poly-L-lactic acid (PLLA)
  • Experimental: microneedling RF treatment with placebo

Primary Outcome Measure

Change in subcutaneous fat pad thickness as measured by high-frequency ultrasound imaging [ Time Frame: Baseline, 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Ying Chen, MD
[email protected]
(713) 486-9400
Robert C Tung
[email protected]
(713) 486-6095

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By research site
The University of Texas Health Science Center at Houston· Houston, TX

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