Treatment of Perioral Wrinkles Using Topical Poly-L-lactic Acid and Microneedling Device
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Global Aesthetic Improvement Scale (GAIS)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Arm A
Topical PLLA applied to perioral region first and then a microneedling treatment performed.
干预措施: Poly-L-Lactic Acid (Drug)
Arm A
Topical PLLA applied to perioral region first and then a microneedling treatment performed.
干预措施: Microneedling (Device)
Arm B
A microneedling treatment is first performed and then topical PLLA is applied.
干预措施: Poly-L-Lactic Acid (Drug)
Arm B
A microneedling treatment is first performed and then topical PLLA is applied.
干预措施: Microneedling (Device)
结局指标
主要结局
Global Aesthetic Improvement Scale (GAIS)
时间窗: 120 days
blinded in person GAIS scores
次要结局
- Lemperle Wrinkle Scale(120 days)
- Canfield VISIA measurements(120 days)
- GAIS(120 days)
研究者
Jessica Labadie
Principal Investigator
Skincare Physicians of Chestnut Hill