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

NCT ID: NCT07261527

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-24

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Skin Texture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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microneedling radiofrequency (RF)

Group Type EXPERIMENTAL

microneedling RF treatment

Intervention Type DEVICE

Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart

no treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

microneedling RF treatment

Intervention Type DEVICE

Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart

PLLA

Intervention Type DEVICE

Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by PLLA application after each treatment

microneedling RF treatment with placebo

Group Type EXPERIMENTAL

microneedling RF treatment

Intervention Type DEVICE

Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart

Sterile Water as control

Intervention Type DRUG

Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by sterile water application after each treatment

Interventions

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microneedling RF treatment

Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart

Intervention Type DEVICE

PLLA

Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by PLLA application after each treatment

Intervention Type DEVICE

Sterile Water as control

Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by sterile water application after each treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Ying Chen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ying Chen, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Ying Chen, MD

Role: CONTACT

(713) 486-9400

Robert C Tung

Role: CONTACT

(713) 486-6095

Facility Contacts

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Ying Chen, MD

Role: primary

(713) 486-9400

Robert C Tung

Role: backup

(713) 486-6095

Other Identifiers

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HSC-MS-25-0585

Identifier Type: -

Identifier Source: org_study_id

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