Characterization of Skin and Facial Fat Pad Thickness Changes Following Microneedling Radiofrequency With and Without Topical Poly-L-Lactic Acid for Facial Rejuvenation

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Skin Texture

Treatments: Drug: Sterile Water as control; Device: PLLA; Device: microneedling RF treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07261527

HSC-MS-25-0585

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 4 patient groups

microneedling radiofrequency (RF)

Experimental group

Treatment:

Device: microneedling RF treatment

no treatment

No Intervention group

microneedling RF treatment with topical poly-L-lactic acid (PLLA)

Experimental group

Treatment:

Device: microneedling RF treatment

Device: PLLA

microneedling RF treatment with placebo

Experimental group

Treatment:

Device: microneedling RF treatment

Drug: Sterile Water as control