Investigating the Safety and Efficacy of the 1927-nm Thulium Laser for Soft Tissue Coagulation in Keratosis Pilaris
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Disease Severity as assessed by the Investigator's Global Assessment (IGA)
研究概览
简要总结
Keratosis pilaris (KP) is a very common skin condition that affects up to 80% of adolescents and 40% of adults. Clinically, KP causes rough dry patches and tiny spiny bumps around the hair follicles, as well as redness and pigmentation changes, most often on the upper arms, thighs, cheeks, or buttocks. While KP is benign, it can be cosmetically very bothersome. Currently, treatment options for KP are limited, and consist of topical moisturizers and keratolytic agents, but often leads to suboptimal improvements. In literature, many laser treatment modalities for KP have been studied, with varying results. The primary aim of this pilot study is to investigate how KP, a predominantly follicular disorder, responds to treatment with the 1927-nm Thulium laser.
详细描述
The non-ablative fractional 1927nm Thulium laser (LaseMD ULTRA) is approved by the Food and Drug Administration (FDA) for use in dermatological procedures requiring soft-tissue coagulation, such as treatment of actinic keratosis (pre-cancerous spots), and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sunspots) and ephelides (freckles). It is not approved for use for soft-tissue coagulation in keratosis pilaris.
It has been used in previous studies to treat conditions including acne scarring, skin rejuvenation, enlarged sebaceous glands, dyschromia, rosacea, and actinic keratoses. Its role as a potential treatment option for KP, remains unexplored.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female or male, in good health, ages 18-65
- •Voluntarily signed informed consent form
- •Any Fitzpatrick skin type (I-VI)
- •Clinically diagnosed keratosis pilaris of bilateral upper arms
- •Willing to have photographs taken and agree to the use of photographs for regulatory, presentation, or marketing purposes
- •Willing and able to follow protocol procedures and requirements
排除标准
- •History of receiving any laser therapy to the bilateral arms in the 12 months before recruitment
- •History of or concurrent use of radiation to the bilateral arms in the 12 months before recruitment
- •Participation of other device or drug clinical trials within 1 month before recruitment
- •Concurrent diagnosis of active skin condition in the arms
- •Presence of an active systemic or local skin disease that may affect wound healing
- •History of forming keloids, collagen vascular disease, chronic drug or alcohol use
- •History of malignant tumors in the upper arms
- •Presence of open ulcers or infections any skin site
- •Presence of a tan or sunburn over the upper arms in the month before recruitment
- •Use of topical or oral photosensitizing medications
- •Excessive body hair or tattoo in target area
- •Pregnant and/or breastfeeding
- •Presence of any medical conditions that interfere with subject's participation
- •History of diagnosed pigmentary disorders in the target area
- •Current smoker or history of smoking within 5 years
研究组 & 干预措施
1927-nm Thulium Laser therapy (right arm)
Participants will receive treatment for Keratosis Pilaris with the 1927-nm Thulium laser on the right arm.
干预措施: 1927-nm Thulium Laser therapy (Device)
1927-nm Thulium Laser therapy (left arm)
Participants will receive treatment for Keratosis Pilaris with the 1927-nm Thulium laser on the left arm.
干预措施: 1927-nm Thulium Laser therapy (Device)
结局指标
主要结局
Disease Severity as assessed by the Investigator's Global Assessment (IGA)
时间窗: 6 weeks, 12 weeks, 18 weeks, 24 weeks, 2 follow up visits up to 3 months
IGA score will be assessed by two blinded dermatologists for each arm based for two categories (erythema and texture/skin roughness) from standardized digital photographs. Scale ranges from 0 (clear) - 3 (severe). Lower score better.
Disease Severity as assessed by the Investigator's Global Assessment (IGA)
时间窗: 6 weeks, 12 weeks, 18 weeks, 24 weeks, 2 follow up visits up to 3 months
IGA score will be assessed by two blinded dermatologists for each arm based for two categories (erythema and texture/skin roughness) from standardized digital photographs. Scale ranges from 0 (clear) - 3 (severe). Lower score better.
次要结局
- Global Improvement Scale (GIS)(24 weeks, 2 follow up visits up to 3 months)
- Participant Satisfaction(24 weeks, 2 follow up visits up to 3 months)
- Global Improvement Scale (GIS)(24 weeks, 2 follow up visits up to 3 months)
- Participant Satisfaction(24 weeks, 2 follow up visits up to 3 months)