Perioral WrinklesPhase 4NCT07225348
Treatment of Perioral Wrinkles Using Topical Poly-L-lactic Acid and Microneedling Device
A Phase 4 study testing Poly-L-Lactic Acid and Microneedling in people with Perioral Wrinkles, run by Skincare Physicians of Chestnut Hill at 1 site in United States.
Trial summary
The first goal of this clinical trial is to learn if topical application of PLLA in conjunction with a microneedling treatment works to treat perioral wrinkles in adults. The second goal is to see whether the application of topical PLLA is more effective before or after a microneedling treatment. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Perioral Wrinkles
- What is being tested?
- Poly-L-Lactic Acid and Microneedling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2025to 1 Oct 2026
- Phase
- Phase 4
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and non-pregnant, non-lactating females 40-70 years of age
- Fitzpatrick Skin Type I-IV
- Wrinkle severity graded by the investigator (1-3 on Lemperle scale)
- Able to provide written informed consent, understand and be willing to comply with all study related procedures and follow-up visits
- Signed informed consent obtained before any study-specific procedure is performed.
Who cannot join
- Lesions suspicious for any malignancy, actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the area to be treated
- Tenderness in the treatment rea
- History of keloid formation or hypertrophic scarring
- History of trauma or surgery to the treatment area
- Scar present in the areas to be treated
- Silicone or synthetic material injections in the areas to be treated
Show all 21Show fewer
- Injection of fat, collagen, hyaluronic acid or other dermal fillers in the areas to be treated within the previous 12 months
- History of treatment with dermabrasion or laser in the areas to be treated within the previous 12 months
- History of treatment with botulinum toxin injections in the areas to be treated within the prior 6 months
- Active smokers (0.5 pack/day) or having quit within 3 months prior treatment
- Active, chronic, or recurrent infection
- History of compromised immune system or currently being treated with immunosuppressive agents
- History of sensitivity to analgesic agents, Aquaphor, topical or local anesthetics
- Excessive sun exposure and use of tanning beds or tanning creams within 30 days prior to treatment
- Treatment with fish oil within 14 days prior to treatment
- Treatment with aspirin or other blood thinning agents within 14 days prior to treatment
- History or presence of any clinically significant bleeding disorder
- Co-morbid condition that in the Investigator's opinion could limit ability to participate in the study or to comply with follow-up requirements
- History of drug and/or alcohol abuse
- Any issue that, at the discretion of the investigator, would interfere with assessment of safety or efficacy or compromise the subject's ability to safely undergo study procedures or give informed consent
- Treatment with an investigational device or agent within 30 days before treatment or during the study period
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, 1 recruiting
- Recruiting
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467
Joaninha Barbosa, BS, 6177311600 ext. 1625, jdepina@skincarephysicians.net
Jessica G Labadie, MD, 6176936125 ext. 1750, jlabadie@skincarephysicians.net
About this study
The first goal of this clinical trial is to learn if topical application of PLLA in conjunction with a microneedling treatment works to treat perioral wrinkles in adults. The second goal is to see whether the application of topical PLLA is more effective before or after a microneedling treatment. The main questions it aims to answer are:
- Is PLLA present within the MN channels from in vivo biopsy samples?
- Is it safe to combine topical PLLA and MN in the treatment of perioral wrinkles, as determined by the incidence and severity of adverse events in healthy subjects?
- Does overall aesthetic and skin texture improve in combining microneedling with topical PLLA in the treatment of mild to moderate perioral wrinkles?
- Is it the treatment of topical PLLA more effective when applied before or after a microneedling treatment.
Read more
Researchers will compare the application of PLLA before a microneedling treatment to a microneedling treatment with PLLA application after to see which treatment method is more effective.
Participants will:
- receive 2 treatments spaced 4-6 weeks apart of topical PLLA and microneedling
- Conditions
- Perioral Wrinkles
- Being tested
- Poly-L-Lactic Acid, Microneedling
- Keywords
- perioral wrinkles, microneedling, poly-L-lactic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly-L-Lactic AcidDrug
Also called Sculptra
Topical PLLA diluted with 8cc of sterile water
MicroneedlingDevice
Also called Eclipse Skin Pen with glide OR MD needle Pen
Microneedling treatment of the perioral region
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Topical PLLA applied to perioral region first and then a microneedling treatment performed. Receives: Drug: Poly-L-Lactic Acid; Device: Microneedling |
| Arm B | Experimental | A microneedling treatment is first performed and then topical PLLA is applied. Receives: Drug: Poly-L-Lactic Acid; Device: Microneedling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Aesthetic Improvement Scale (GAIS)
blinded in person GAIS scores
Measured: 120 days
Secondary outcomes (4)
Lemperle Wrinkle Scale
three blinded raters, who will judge scores of pre- and post-treatment photographs using the Lemperle Wrinkle Scale
Measured: 120 days
Lemperle Wrinkle Scale
treating investigator reported score using the Lemperle Wrinkle Scale
Measured: 120 days
Canfield VISIA measurements
wrinkle severity scores as calculated by the computerized Canfield VISIA measurements
Measured: 120 days
GAIS
subject and treating investigator reported score using the GAIS
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study start7 Nov 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Perioral WrinklesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The results of Part I will directly affect Part II: * If no PLLA is seen in any of the samples from Part I, then we will NOT proceed to the clinical trial in Part II. * If PLLA particles are seen in samples from BOTH protocols, then the clinical trial from part II will proceed as written below. * If PLLA particles are only seen in the samples where the PLLA serum was applied FIRST, then we will DROP Arm B in Part II. * If PLLA particles are only seen in the samples where the PLLA serum was applied second, then we will DROP Arm A in Part II.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skincare Physicians of Chestnut Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Galderma R&D
- Responsible party
- Principal investigator, Jessica Labadie, Skincare Physicians of Chestnut Hill
- Investigators
- Jessica G Labadie, MD, Principal investigator, SkinCare Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225348
- Sponsor's protocol ID
- SkincarePCH
- Status last verified
- Dec 2025
- First submitted
- 3 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Cervantes J, Chang YF, Dover JS, Hernandez Alvarez A, Chung HJ. Laser-Assisted and Device-Assisted Filler Delivery: A Histologic Evaluation. Dermatol Surg. 2023 Sep 1;49(9):865-870. doi: 10.1097/DSS.0000000000003870. Epub 2023 Jun 23.
PubMed 37389474Tian T, Luo Y, Jiang T, Dong Y, Yu A, Chen H, Gao X, Li Y. Clinical effect of ablative fractional laser-assisted topical anesthesia on human skin: A randomized pilot study. J Cosmet Laser Ther. 2016 Nov;18(7):409-412. doi: 10.1080/14764172.2016.1197404. Epub 2016 Aug 5.
PubMed 27419471Taudorf EH. Laser-assisted delivery of topical methotrexate - in vitro investigations. Dan Med J. 2016 Jun;63(6):B5254.
PubMed 27264947Waibel JS, Wulkan AJ, Shumaker PR. Treatment of hypertrophic scars using laser and laser assisted corticosteroid delivery. Lasers Surg Med. 2013 Mar;45(3):135-40. doi: 10.1002/lsm.22120. Epub 2013 Mar 4.
PubMed 23460557Ibrahim O, Ionta S, Depina J, Petrell K, Arndt KA, Dover JS. Safety of Laser-Assisted Delivery of Topical Poly-L-Lactic Acid in the Treatment of Upper Lip Rhytides: A Prospective, Rater-Blinded Study. Dermatol Surg. 2019 Jul;45(7):968-974. doi: 10.1097/DSS.0000000000001743.
PubMed 30608292Rkein A, Ozog D, Waibel JS. Treatment of atrophic scars with fractionated CO2 laser facilitating delivery of topically applied poly-L-lactic acid. Dermatol Surg. 2014 Jun;40(6):624-31. doi: 10.1111/dsu.0000000000000010.
PubMed 24852466Physicochemical Characteristics and Hydrolytic Degradation of Polylactic Acid Dermal Fillers: A Comparative Study Nikita G. Sedush 1,* , Kirill T. Kalinin 1, Pavel N. Azarkevich 1 and Antonina A. Gorskaya
Courderot-Masuyer C, Robin S, Tauzin H, et al. Evaluation of the behaviour of wrinkles fibroblasts and normal aged fibroblasts in the presence of poly-L-lactic acid. J Cosmet Dermatol Sci Appl 2012;2:20
Orringer JS, Kang S, Johnson TM, Karimipour DJ, Hamilton T, Hammerberg C, Voorhees JJ, Fisher GJ. Connective tissue remodeling induced by carbon dioxide laser resurfacing of photodamaged human skin. Arch Dermatol. 2004 Nov;140(11):1326-32. doi: 10.1001/archderm.140.11.1326.
PubMed 15545540Branham GH, Thomas JR. Rejuvenation of the skin surface: chemical peel and dermabrasion. Facial Plast Surg. 1996 Apr;12(2):125-33. doi: 10.1055/s-0028-1082404.
PubMed 9220727Nikolis A, Bernstein S, Kinney B, Scuderi N, Rastogi S, Sampalis JS. A randomized, placebo-controlled, single-blinded, split-faced clinical trial evaluating the efficacy and safety of KLOX-001 gel formulation with KLOX light-emitting diode light on facial rejuvenation. Clin Cosmet Investig Dermatol. 2016 May 13;9:115-25. doi: 10.2147/CCID.S100697. eCollection 2016.
PubMed 27257391Airan LE, Hruza G. Current lasers in skin resurfacing. Facial Plast Surg Clin North Am. 2005 Feb;13(1):127-39. doi: 10.1016/j.fsc.2004.06.005.
PubMed 15519933
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Perioral Wrinkles Using Topical Poly-L-lactic Acid and Microneedling Device
- ClinicalTrials.gov ID
- NCT07225348
- Acronym / sponsor ID
- SkincarePCH
- Conditions
- Perioral Wrinkles
- Keywords
- perioral wrinkles, microneedling, poly-L-lactic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Skincare Physicians of Chestnut HillUniversity, hospital or other
- Collaborators
- Galderma R&D
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 6 Nov 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 first goal of this clinical trial is to learn if topical application of PLLA in conjunction with a microneedling treatment works to treat perioral wrinkles in adults. The second goal is to see whether the application of topical PLLA is more effective before or after a microneedling treatment. The main questions it aims to answer are:
- Is PLLA present within the MN channels from in vivo biopsy samples?
- Is it safe to combine topical PLLA and MN in the treatment of perioral wrinkles, as determined by the incidence and severity of adverse events in healthy subjects?
- Does overall aesthetic and skin texture improve in combining microneedling with topical PLLA in the treatment of mild to moderate perioral wrinkles?
- Is it the treatment of topical PLLA more effective when applied before or after a microneedling treatment.
Researchers will compare the application of PLLA before a microneedling treatment to a microneedling treatment with PLLA application after to see which treatment method is more effective.
Participants will:
- receive 2 treatments spaced 4-6 weeks apart of topical PLLA and microneedling
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The results of Part I will directly affect Part II: * If no PLLA is seen in any of the samples from Part I, then we will NOT proceed to the clinical trial in Part II. * If PLLA particles are seen in samples from BOTH protocols, then the clinical trial from part II will proceed as written below. * If PLLA particles are only seen in the samples where the PLLA serum was applied FIRST, then we will DROP Arm B in Part II. * If PLLA particles are only seen in the samples where the PLLA serum was applied second, then we will DROP Arm A in Part II.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Poly-L-Lactic Acid, Device: MicroneedlingTopical PLLA applied to perioral region first and then a microneedling treatment performed. |
| Arm B | Experimental | Drug: Poly-L-Lactic Acid, Device: MicroneedlingA microneedling treatment is first performed and then topical PLLA is applied. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and non-pregnant, non-lactating females 40-70 years of age
- Fitzpatrick Skin Type I-IV
- Wrinkle severity graded by the investigator (1-3 on Lemperle scale)
- Able to provide written informed consent, understand and be willing to comply with all study related procedures and follow-up visits
- Signed informed consent obtained before any study-specific procedure is performed.
Key exclusion criteria (21 listed)
- Lesions suspicious for any malignancy, actinic keratosis, melasma, vitiligo, cutaneous papules/nodules or active inflammatory lesions in the area to be treated
- Tenderness in the treatment rea
- History of keloid formation or hypertrophic scarring
- History of trauma or surgery to the treatment area
- Scar present in the areas to be treated
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 |
|---|---|---|
| Poly-L-Lactic AcidAlso: SculptraTopical PLLA diluted with 8cc of sterile water | Drug | Arm A, Arm B |
| MicroneedlingAlso: Eclipse Skin Pen with glide OR MD needle PenMicroneedling treatment of the perioral region | Device | Arm A, Arm B |
Primary outcome
Global Aesthetic Improvement Scale (GAIS)
Time frame: 120 days
blinded in person GAIS scores
4 secondary outcomes
Lemperle Wrinkle Scale
Time frame: 120 days
Lemperle Wrinkle Scale
Time frame: 120 days
Canfield VISIA measurements
Time frame: 120 days
GAIS
Time frame: 120 days
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 5 Dec 2025.
- Background: PubMed 37389474Cervantes J, Chang YF, Dover JS, Hernandez Alvarez A, Chung HJ. Laser-Assisted and Device-Assisted Filler Delivery: A Histologic Evaluation. Dermatol Surg. 2023 Sep 1;49(9):865-870. doi: 10.1097/DSS.0000000000003870. Epub 2023 Jun 23.
- Background: PubMed 27419471Tian T, Luo Y, Jiang T, Dong Y, Yu A, Chen H, Gao X, Li Y. Clinical effect of ablative fractional laser-assisted topical anesthesia on human skin: A randomized pilot study. J Cosmet Laser Ther. 2016 Nov;18(7):409-412. doi: 10.1080/14764172.2016.1197404. Epub 2016 Aug 5.
- Background: PubMed 27264947Taudorf EH. Laser-assisted delivery of topical methotrexate - in vitro investigations. Dan Med J. 2016 Jun;63(6):B5254.
- Background: PubMed 23460557Waibel JS, Wulkan AJ, Shumaker PR. Treatment of hypertrophic scars using laser and laser assisted corticosteroid delivery. Lasers Surg Med. 2013 Mar;45(3):135-40. doi: 10.1002/lsm.22120. Epub 2013 Mar 4.
- Background: PubMed 30608292Ibrahim O, Ionta S, Depina J, Petrell K, Arndt KA, Dover JS. Safety of Laser-Assisted Delivery of Topical Poly-L-Lactic Acid in the Treatment of Upper Lip Rhytides: A Prospective, Rater-Blinded Study. Dermatol Surg. 2019 Jul;45(7):968-974. doi: 10.1097/DSS.0000000000001743.
- Background: PubMed 24852466Rkein A, Ozog D, Waibel JS. Treatment of atrophic scars with fractionated CO2 laser facilitating delivery of topically applied poly-L-lactic acid. Dermatol Surg. 2014 Jun;40(6):624-31. doi: 10.1111/dsu.0000000000000010.
- BackgroundPhysicochemical Characteristics and Hydrolytic Degradation of Polylactic Acid Dermal Fillers: A Comparative Study Nikita G. Sedush 1,* , Kirill T. Kalinin 1, Pavel N. Azarkevich 1 and Antonina A. Gorskaya
- BackgroundCourderot-Masuyer C, Robin S, Tauzin H, et al. Evaluation of the behaviour of wrinkles fibroblasts and normal aged fibroblasts in the presence of poly-L-lactic acid. J Cosmet Dermatol Sci Appl 2012;2:20
- Background: PubMed 15545540Orringer JS, Kang S, Johnson TM, Karimipour DJ, Hamilton T, Hammerberg C, Voorhees JJ, Fisher GJ. Connective tissue remodeling induced by carbon dioxide laser resurfacing of photodamaged human skin. Arch Dermatol. 2004 Nov;140(11):1326-32. doi: 10.1001/archderm.140.11.1326.
- Background: PubMed 9220727Branham GH, Thomas JR. Rejuvenation of the skin surface: chemical peel and dermabrasion. Facial Plast Surg. 1996 Apr;12(2):125-33. doi: 10.1055/s-0028-1082404.
- Background: PubMed 27257391Nikolis A, Bernstein S, Kinney B, Scuderi N, Rastogi S, Sampalis JS. A randomized, placebo-controlled, single-blinded, split-faced clinical trial evaluating the efficacy and safety of KLOX-001 gel formulation with KLOX light-emitting diode light on facial rejuvenation. Clin Cosmet Investig Dermatol. 2016 May 13;9:115-25. doi: 10.2147/CCID.S100697. eCollection 2016.
- Background: PubMed 15519933Airan LE, Hruza G. Current lasers in skin resurfacing. Facial Plast Surg Clin North Am. 2005 Feb;13(1):127-39. doi: 10.1016/j.fsc.2004.06.005.
- Individual participant dataSharing planned: No
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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.
Jessica G Labadie, MD principal investigator
SkinCare Physicians
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Poly-L-Lactic Acid and Microneedling in people with Perioral Wrinkles, run by Skincare Physicians of Chestnut Hill 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 5 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 5 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jessica G Labadie, MD (6176936125 ext. 1705, jlabadie@skincarephysicians.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Aesthetic Improvement Scale (GAIS) (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07225348, which also lists 12 linked publications.
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 5 Dec 2025.