Skin TextureNCT07261527
Characterization of Skin and Facial Fat Pad Thickness Changes Following Microneedling Radiofrequency With and Without Topical Poly-L-Lactic Acid for Facial Rejuvenation
A study testing microneedling RF treatment and PLLA in people with Skin Texture, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Texture
- What is being tested?
- microneedling RF treatment and PLLA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2025to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Seeking facial rejuvenation for cosmetic concerns
- Able and willing to provide informed consent
- Willing to comply with study procedures and follow-up visits
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Ying Chen, MD, (713) 486-9400, ying.chen@uth.tmc.edu
Robert C Tung, (713) 486-6095, Robert.C.Tung@uth.tmc.edu
About this study
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.
- Conditions
- Skin Texture
- Being tested
- microneedling RF treatment, PLLA, Sterile Water as control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microneedling RF treatmentDevice
Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart
PLLADevice
Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by PLLA application after each treatment
Sterile Water as controlDrug
Participants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by sterile water application after each treatment
| Study group | Role | What they receive |
|---|---|---|
| microneedling radiofrequency (RF) | Experimental | Not described Receives: Device: microneedling RF treatment |
| no treatment | No intervention | Not described |
| microneedling RF treatment with topical poly-L-lactic acid (PLLA) | Experimental | Not described Receives: Device: microneedling RF treatment; Device: PLLA |
| microneedling RF treatment with placebo | Experimental | Not described Receives: Device: microneedling RF treatment; Drug: Sterile Water as control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subcutaneous fat pad thickness as measured by high-frequency ultrasound imaging
Measured: Baseline, 6 months
Secondary outcomes (6)
Difference in fat pad thickness between the RF+PLLA side and RF-only side as assessed by ultrasound imaging
Measured: 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
Measured: 6 months
Change in satisfaction with forehead as assessed by the patient questionnaire
This is scored from 1 (lowest) to 10 (highest)
Measured: Baseline, 6 months
Change in satisfaction with cheek as assessed by the patient questionnaire
This is scored from 1 (lowest) to 9 (highest)
Measured: Baseline, 6 months
Change in satisfaction with submental as assessed by the patient questionnaire
This is scored from 1 (lowest) to 9 (highest)
Measured: Baseline, 6 months
Change in overall social confidence as assessed by the patient questionnaire
This is scored from 1 (lowest) to 10 (highest)
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start24 Nov 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin TextureStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Chen, The University of Texas Health Science Center, Houston
- Investigators
- Ying Chen, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261527
- Sponsor's protocol ID
- HSC-MS-25-0585
- Status last verified
- Nov 2025
- First submitted
- 22 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Skin and Facial Fat Pad Thickness Changes Following Microneedling Radiofrequency With and Without Topical Poly-L-Lactic Acid for Facial Rejuvenation
- ClinicalTrials.gov ID
- NCT07261527
- Acronym / sponsor ID
- HSC-MS-25-0585
- Conditions
- Skin Texture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 24 Nov 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| microneedling radiofrequency (RF) | Experimental | Device: microneedling RF treatment |
| no treatment | No intervention | – |
| microneedling RF treatment with topical poly-L-lactic acid (PLLA) | Experimental | Device: microneedling RF treatment, Device: PLLA |
| microneedling RF treatment with placebo | Experimental | Device: microneedling RF treatment, Drug: Sterile Water as control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Seeking facial rejuvenation for cosmetic concerns
- Able and willing to provide informed consent
- Willing to comply with study procedures and follow-up visits
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microneedling RF treatmentParticipants will undergo two microneedling RF treatment sessions, 4-6 weeks apart | Device | microneedling RF treatment with placebo, microneedling RF treatment with topical poly-L-lactic acid (PLLA), microneedling radiofrequency (RF) |
| PLLAParticipants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by PLLA application after each treatment | Device | microneedling RF treatment with topical poly-L-lactic acid (PLLA) |
| Sterile Water as controlParticipants will undergo two microneedling RF treatment sessions, 4-6 weeks apart followed by sterile water application after each treatment | Drug | microneedling RF treatment with placebo |
Primary outcome
Change in subcutaneous fat pad thickness as measured by high-frequency ultrasound imaging
Time frame: Baseline, 6 months
6 secondary outcomes
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
Time frame: 6 months
Change in satisfaction with forehead as assessed by the patient questionnaire
Time frame: Baseline, 6 months
Change in satisfaction with cheek as assessed by the patient questionnaire
Time frame: Baseline, 6 months
Change in satisfaction with submental as assessed by the patient questionnaire
Time frame: Baseline, 6 months
Change in overall social confidence as assessed by the patient questionnaire
Time frame: Baseline, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ying Chen, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing microneedling RF treatment and PLLA in people with Skin Texture, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Chen, MD ((713) 486-9400, ying.chen@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subcutaneous fat pad thickness as measured by high-frequency ultrasound imaging (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.