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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Texture
• Intervention / Treatment: Device: microneedling RF treatment; Device: PLLA; Drug: Sterile Water as control

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ying Chen, MD; Phone Number: (713) 486-9400; Email: ying.chen@uth.tmc.edu
• Study Contact Backup: Name: Robert C Tung; Phone Number: (713) 486-6095; Email: Robert.C.Tung@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Ying Chen, MD; Phone Number: (713) 486-9400; Email: ying.chen@uth.tmc.edu
      • Contact: Robert C Tung; Phone Number: (713) 486-6095; Email: Robert.C.Tung@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Seeking facial rejuvenation for cosmetic concerns
• Able and willing to provide informed consent
• Willing to comply with study procedures and follow-up visits

Exclusion Criteria:

• Prior filler injection or energy-based device treatment to the face within the past 6 months
• Previous facial surgeries
• Pregnant or breastfeeding
• Active infection, dermatitis, or open lesions in the treatment area
• History of keloids or abnormal scarring
• Known allergy to poly-L-lactic acid (PLLA)- Current participation in another clinical trial involving facial aesthetic treatments
• Presence of pre-cancerous or cancerous lesions in the treatment area
• Current or planned use of glucagon-like peptide-1 receptor agonists (e.g., Ozempic, semaglutide) during the study period. Subjects on these medications will be excluded due to potential effects on facial fat and overall weight.
• HIV+ patients
• Patients on HIV medications- Patients that have eczema and rosacea

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: no treatment
Experimental: microneedling radiofrequency (RF)	Device: microneedling RF treatment; Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart
Experimental: microneedling RF treatment with topical poly-L-lactic acid (PLLA)	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
Experimental: microneedling RF treatment with placebo	Device: microneedling RF treatment; Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in fat pad thickness between the RF+PLLA side and RF-only side as assessed by ultrasound imaging		6 months
Patient reported overall improvement in appearance as assessed by the Global Aesthetic Scale	This is scored on a 5 point scale from 1(much worse) to 5 (much improved) , higher score indicating better outcome	6 months
Change in satisfaction with forehead as assessed by the patient questionnaire	This is scored from 1 (lowest) to 10 (highest)	Baseline, 6 months
Change in satisfaction with cheek as assessed by the patient questionnaire	This is scored from 1 (lowest) to 9 (highest)	Baseline, 6 months
Change in satisfaction with submental as assessed by the patient questionnaire	This is scored from 1 (lowest) to 9 (highest)	Baseline, 6 months
Change in overall social confidence as assessed by the patient questionnaire	This is scored from 1 (lowest) to 10 (highest)	Baseline, 6 months

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Ying Chen, MD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): November 24, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: November 22, 2025
• First Submitted That Met QC Criteria: November 22, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 22, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: HSC-MS-25-0585

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No