Perioral Wrinkles
Conditions
Keywords
perioral wrinkles, microneedling, poly-L-lactic acid
Brief 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. 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
Interventions
Topical PLLA diluted with 8cc of sterile water
DEVICEMicroneedling
Microneedling treatment of the perioral region
Sponsors
Galderma R&D
Skincare Physicians of Chestnut Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Aesthetic Improvement Scale (GAIS) | 120 days | blinded in person GAIS scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Canfield VISIA measurements | 120 days | wrinkle severity scores as calculated by the computerized Canfield VISIA measurements |
| GAIS | 120 days | subject and treating investigator reported score using the GAIS |
| Lemperle Wrinkle Scale | 120 days | three blinded raters, who will judge scores of pre- and post-treatment photographs using the Lemperle Wrinkle Scale |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 120 days | the incidence and severity of systemic and cutaneous adverse events |
| Histologic endpoint | 120 days | PLLA particles visualized within MN channels on H&E with polariscopic examination |
| Molecular Endpoint | 120 days | Molecular testing (Gene Markers) |
Countries
United States
Contacts
Primary ContactJessica G Labadie, MD
Backup ContactJoaninha Barbosa, BS
Outcome results
None listed