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

NCT07261527 | Not Yet Recruiting FDA Device

• 1 other identifier: HSC-MS-25-0585
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in subcutaneous fat pad thickness as measured by high-frequency ultrasound imaging

  Baseline, 6 months

Secondary Outcomes (6)

• 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

  6 months

• Change in satisfaction with forehead as assessed by the patient questionnaire

  Baseline, 6 months

• Change in satisfaction with cheek as assessed by the patient questionnaire

  Baseline, 6 months

• Change in satisfaction with submental as assessed by the patient questionnaire

  Baseline, 6 months

Study Arms (4)

microneedling radiofrequency (RF)

EXPERIMENTAL

Device: microneedling RF treatment

no treatment

NO INTERVENTION

microneedling RF treatment with topical poly-L-lactic acid (PLLA)

EXPERIMENTAL

Device: microneedling RF treatment; Device: PLLA

microneedling RF treatment with placebo

EXPERIMENTAL

Device: microneedling RF treatment; Drug: Sterile Water as control

Interventions

microneedling RF treatment DEVICE

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

microneedling RF treatment with placebo; microneedling RF treatment with topical poly-L-lactic acid (PLLA); microneedling radiofrequency (RF)

PLLA DEVICE

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

microneedling RF treatment with topical poly-L-lactic acid (PLLA)

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

microneedling RF treatment with placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Study Officials

• Ying Chen, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Chen, MD

CONTACT

(713) 486-9400; ying.chen@uth.tmc.edu

Robert C Tung

CONTACT

(713) 486-6095; Robert.C.Tung@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 22, 2025
• First Posted: December 3, 2025
• Study Start: November 24, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

US (1)