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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

ConditionSkin Texture
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Seeking facial rejuvenation for cosmetic concerns

Able and willing to provide informed consent

Willing to comply with study procedures and follow-up visits

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

30 Participants
are divided into 4 treatment groups
Group A: microneedling radiofrequency (RF)Experimental treatment 1 intervention
Group B: no treatmentNo intervention 0 interventions
Group C: microneedling RF treatment with topical poly-L-lactic acid (PLLA)Experimental treatment 2 interventions
Group D: microneedling RF treatment with placeboExperimental treatment 2 interventions

Trial outcomes

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

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

Time frame
6 months
3

Change in satisfaction with forehead as assessed by the patient questionnaire

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

Time frame
Baseline, 6 months
4

Change in satisfaction with cheek as assessed by the patient questionnaire

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

Time frame
Baseline, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: