Skin Texture
Conditions
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.
Interventions
Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by sterile water application after each treatment
DEVICEPLLA
Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by PLLA application after each treatment
DEVICEmicroneedling RF treatment
Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in subcutaneous fat pad thickness as measured by high-frequency ultrasound imaging | Baseline, 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | This is scored on a 5 point scale from 1(much worse) to 5 (much improved) , higher score indicating better outcome |
| Change in satisfaction with forehead as assessed by the patient questionnaire | Baseline, 6 months | This is scored from 1 (lowest) to 10 (highest) |
| Change in satisfaction with cheek as assessed by the patient questionnaire | Baseline, 6 months | This is scored from 1 (lowest) to 9 (highest) |
| Change in satisfaction with submental as assessed by the patient questionnaire | Baseline, 6 months | This is scored from 1 (lowest) to 9 (highest) |
| Change in overall social confidence as assessed by the patient questionnaire | Baseline, 6 months | This is scored from 1 (lowest) to 10 (highest) |
Countries
United States
Contacts
Primary ContactYing Chen, MD
Backup ContactRobert C Tung
Outcome results
None listed