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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| microneedling radiofrequency (RF) | Experimental |
| |
| no treatment | No Intervention | ||
| microneedling RF treatment with topical poly-L-lactic acid (PLLA) | Experimental |
| |
| microneedling RF treatment with placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| microneedling RF treatment | Device | Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in subcutaneous fat pad thickness as measured by high-frequency ultrasound imaging | Baseline, 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Ying Chen, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| 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 |
|
| 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 |