NCT07225348 · Skincare Physicians of Chestnut Hill
Treatment of Perioral Wrinkles Using Topical Poly-L-lactic Acid and Microneedling Device
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Poly-L-Lactic Acid
Topical PLLA diluted with 8cc of sterile water
DEVICE
Microneedling
Microneedling treatment of the perioral region
Primary outcome measures
Global Aesthetic Improvement Scale (GAIS)
Time frame: 120 days
blinded in person GAIS scores
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- 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
Where
- Chestnut Hill, Massachusetts
Collaborators
Galderma R&D
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 5, 2025 · Source of record for eligibility and locations