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NCT Number: NCT07261527

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.

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Key information

Conditions

Skin Texture

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

    Time frame: Baseline, 6 months

Secondary outcomes

  1. Difference in fat pad thickness between the RF+PLLA side and RF-only side as assessed by ultrasound imaging

    Time frame: 6 months

  2. Patient reported overall improvement in appearance as assessed by the Global Aesthetic Scale

    Time frame: 6 months

    This is scored on a 5 point scale from 1(much worse) to 5 (much improved) , higher score indicating better outcome

  3. Change in satisfaction with forehead as assessed by the patient questionnaire

    Time frame: Baseline, 6 months

    This is scored from 1 (lowest) to 10 (highest)

  4. Change in satisfaction with cheek as assessed by the patient questionnaire

    Time frame: Baseline, 6 months

    This is scored from 1 (lowest) to 9 (highest)

  5. Change in satisfaction with submental as assessed by the patient questionnaire

    Time frame: Baseline, 6 months

    This is scored from 1 (lowest) to 9 (highest)

  6. Change in overall social confidence as assessed by the patient questionnaire

    Time frame: Baseline, 6 months

    This is scored from 1 (lowest) to 10 (highest)

Study contacts

Contact information is provided by the study sponsor or research team.

Robert C Tung

CONTACT

[email protected]

(713) 486-6095

Ying Chen, MD

CONTACT

[email protected]

(713) 486-9400

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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