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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart
Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by PLLA application after each treatment
Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by sterile water application after each treatment
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Change in subcutaneous fat pad thickness as measured by high-frequency ultrasound imaging
Time frame: Baseline, 6 months
Difference in fat pad thickness between the RF+PLLA side and RF-only side as assessed by ultrasound imaging
Time frame: 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
Time frame: 6 months
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
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
Change in satisfaction with submental as assessed by the patient questionnaire
This is scored from 1 (lowest) to 9 (highest)
Time frame: Baseline, 6 months
Change in overall social confidence as assessed by the patient questionnaire
This is scored from 1 (lowest) to 10 (highest)
Time frame: Baseline, 6 months
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