UVA-1 for Treatment of Skin Tightening and Improvement of Hand Function in Scleroderma: a Randomized, Intra-patient, Dominant/non-dominant Hand Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- HAMIS score of treated hand compared to the HAMIS score of the untreated hand after 30 UVA-1 treatments have been completed.
研究概览
简要总结
UVA-1 has been reported to be beneficial to skin changes in scleroderma in several case reports and a few small studies. (Jacobe 2020) Interpretation of these reports has been difficult based on the small numbers of subjects involved and the non-blinded non-randomized nature of the reports. In a single controlled study with half-side comparison of 9 patients, the investigators could not demonstrate improvement with UVA-1 in the treated hand. (Thomas 2007) This study was limited by a small number of patients and the long disease duration prior to treatment (mean of 13 years). A more recent report of a patient with scleroderma for 2.5 years and severe acrosclerosis that responded to 21 sessions of UVA-1 with improved mobility and functionality renews interest in this treatment modality. (Cuenca-Barrales 2019)
In this trial patients will be randomized to have their dominant or non-dominant hand undergo 30 sessions of UVA1 therapy . We will assess patient's hand mobility, hand function, skin hardening (assessed by durometer measurements), skin thickness, as well as patient reported outcomes to determine efficacy.
This study will use a single-blind, prospective, randomized (dominant/non-dominant hand) comparator design to assess the effect of high dose (80-120 J/cm2) UVA1 therapy on hand function in scleroderma in a paired t-test design. This study will be placebo-controlled (with a UV-blocking gloved hand), cross-over, randomized clinical trial. Following the initial treatment period (30 treatments), patients will have the option to undergo the same high dose UVA1 treatment protocol on the untreated control hand. A follow up period of 12 months following completion of UVA1 therapy will prospectively follow patients to monitor for relapse of their disease to assess the durability of the clinical response to UVA1 therapy on hand scleroderma.
详细描述
Systemic sclerosis (SSc), also called scleroderma, is a rare chronic autoimmune disease that can have a wide range of cutaneous, joint, and internal organ involvement. In the skin, SSc is characterized by enhanced fibroblast activity leading to hypertrophic dermal collagen that results in thickened, less flexible skin. (Hassani, 2016) SSc is often divided into two types based on extent of cutaneous involvement: diffuse SSc and limited SSc. The hand is a frequent area of involvement in both subtypes of SSc. Hand disability in SSc leads to a high burden on quality of life for patients as it limits both work and activities of daily living. Treatment for hand sclerosis remains limited with generally progressive disease despite aggressive treatment with anti-fibrotic medications, immunosuppressive agents, and topical approaches. Specific hand therapies include physiotherapy and injections of autologous adipose-derived stromal vascular fraction into the fingers with some success. (Guillaume-Jugnot, 2016; Liem, 2019)
Ultraviolet therapy has been used in dermatology for several decades. UVA-1 is a form of phototherapy that utilizes the longest wavelengths in the UV spectrum from 340-400 nm. It is able to penetrate deeper in the skin than other types of phototherapy and target different types of cells including fibroblasts. In sclerosing skin conditions UVA-1 appears to be superior to other forms of UV light. Medium to high dose UVA-1 also appears to be superior to low dose UVA-1 for sclerosing conditions. (Kreuter 2006).
UVA-1 has been reported to be beneficial to skin changes in SSc in several case reports and a few small studies. (Jacobe 2020) Interpretation of these reports has been difficult based on the small numbers of subjects involved and the non-blinded non-randomized nature of the reports. In a single controlled study with half-side comparison of 9 patients, the investigators could not demonstrate improvement with UVA-1 in the treated hand. (Thomas 2007) This study was limited by a small number of patients and the long disease duration prior to treatment (mean of 13 years). A more recent report of a patient with SSc for 2.5 years and severe acrosclerosis that responded to 21 sessions of UVA-1 with improved mobility and functionality renews interest in this treatment modality. (Cuenca-Barrales 2019)
If UVA1 therapy can significantly improve hand involvement in SSc with regards to functionality and disability, it may be a cost-effective and beneficial treatment for this patient segment with debilitating disease.
Purpose and Objectives:
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 (Investigator)
盲法说明
Investigator will be blinded to which hand was treated, and be the blinded assessor.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be able to understand and provide written informed consent
- •Scleroderma skin involvement affecting both hands approximately equally
- •Age of at least 18-years-old
- •Male or female
- •Ability to engage in twice weekly UVA1 sessions
- •No changes in systemic therapy during the first 100 days of the study period
排除标准
- •On photosensitizing medication
- •Inability to complete study visits
- •UV light therapy in the 4 weeks prior to entering the study
- •Commercial tanning or excessive sun exposure in the 4 weeks prior to entering the study
- •Current pregnancy or planned pregnancy during the study period
- •Use of topical therapies other than emollients (suprapotent corticosteroids) in the 2 weeks prior to entering the study
- •History of intolerance to ultraviolet light
- •Any other condition that will disqualify the patient from the study in the opinion of the investigator
结局指标
主要结局
HAMIS score of treated hand compared to the HAMIS score of the untreated hand after 30 UVA-1 treatments have been completed.
时间窗: Approximately 100 days
HAMIS graded on a 0-3 scale, where 0 corresponds to normal function and 3 denotes that the individual is unable to perform the item.
次要结局
- Change in HDISS-DU from baseline to after 30 UVA-1 treatments of treated hand.(Approximately 100 days)
- Change in HAMIS score from baseline to after 30 UVA-1 treatments of treated hand.(Approximately 100 days)
- Change in CHFDS score from baseline to after 30 UVA-1 treatments of treated hand.(Approximately 100 days)
- Change in skin hardness from baseline to after 30 UVA-1 treatments of treated hand.(Approximately 100 days)
- Change in MHQ scores from baseline to after 30 UVA-1 treatments of treated hand.(Approximately 100 days)
- Change in skin thickness from baseline to after 30 UVA-1 treatments of treated hand.(Approximately 100 days)
- Change in Skindex-16 score from baseline to after 30 UVA-1 treatments of treated hand.(Approximately 100 days)
- Change in PROMIS-PF scores from baseline to after 30 UVA-1 treatments of treated hand.(Approximately 100 days)
研究者
Christopher B Hansen
Dr.
University of Utah