Actively Recruiting
Treatment of Perioral Wrinkles Using Topical Poly-L-lactic Acid and Microneedling Device
Led by Skincare Physicians of Chestnut Hill · Updated on 2025-12-05
26
Participants Needed
1
Research Sites
46 weeks
Total Duration
On this page
Sponsors
S
Skincare Physicians of Chestnut Hill
Lead Sponsor
G
Galderma R&D
Collaborating Sponsor
AI-Summary
What this Trial 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. 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
CONDITIONS
Official Title
Treatment of Perioral Wrinkles Using Topical Poly-L-lactic Acid and Microneedling Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and non-pregnant, non-lactating females aged 40 to 70 years
- Fitzpatrick Skin Type I-IV
- Wrinkle severity graded 1-3 on Lemperle scale by investigator
- Able to provide written informed consent and comply with study procedures and follow-up visits
- Signed informed consent obtained before any study-specific procedure
You will not qualify if you...
- Lesions suspicious for malignancy, actinic keratosis, melasma, vitiligo, cutaneous papules/nodules, or active inflammatory lesions in treatment area
- Tenderness in treatment area
- History of keloid formation or hypertrophic scarring
- History of trauma or surgery to treatment area
- Scar present in areas to be treated
- Silicone or synthetic material injections in treatment areas
- Injection of fat, collagen, hyaluronic acid, or dermal fillers within previous 12 months
- Dermabrasion or laser treatment in treatment areas within previous 12 months
- Botulinum toxin injections in treatment areas within prior 6 months
- Active smokers (0.5 pack/day) or quit within 3 months prior to treatment
- Active, chronic, or recurrent infection
- History of compromised immune system or current immunosuppressive treatment
- Sensitivity to analgesic agents, Aquaphor, topical or local anesthetics
- Excessive sun exposure or tanning bed use within 30 days prior to treatment
- Treatment with fish oil within 14 days prior to treatment
- Treatment with aspirin or blood thinners within 14 days prior to treatment
- History or presence of significant bleeding disorder
- Co-morbid condition limiting participation or follow-up compliance
- History of drug or alcohol abuse
- Any issue interfering with safety, efficacy assessment, or ability to consent
- Treatment with investigational device or agent within 30 days before or during study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
SkinCare Physicians
Chestnut Hill, Massachusetts, United States, 02467
Actively Recruiting
Research Team
J
Jessica G Labadie, MD
CONTACT
J
Joaninha Barbosa, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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