Topical Clobetasol Propionate for Inflammatory Hand Osteoarthritis: A Randomized Trial Versus Placebo
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Change in pain intensity between W0 and W4
研究概览
简要总结
This is a randomized, double-blind, comparative trial evaluating the efficacy on pain intensity between topical Clobetasol Propionate 0.05% and placebo in patients with symptomatic hand osteoarthritis.
详细描述
Symptomatic hand osteoarthritis (HOA) affects 8-16% of the $general population. It includes joint pain and functional disability, inducing a substantial daily burden.
Half of patients have an inflammatory HOA, characterized by the presence of synovitis at interphalangeal (IP) joint which is associated with an increased risk of pain (OR joint pain=2.4 IC95% (1.6-3.8)) and loss of function than in those without inflammatory HOA.
Systemic symptomatic pharmacological treatments of HOA are either poorly effective (ie, paracetamol) or tolerated (ie, oral non-steroidal anti-inflammatory drugs (NSAIDs)) in this elderly population. Studies evaluating systemic drugs (TNF or IL6 inhibitors) failed to show symptomatic efficacy in inflammatory HOA except for oral corticosteroids but with potential severe side effects.
In 2018, EULAR recommended topical treatments over systemic ones for safety issues. Topical NSAIDs are the 1st choice despite modest efficacy, with only 1 randomized placebo-controlled trial showing a significant but modest 7.2 mm difference over placebo on 0-100 mm visual analog scale (VAS) pain at week 4. Other topics such as capsaicin have not relevant efficacy or were not specifically studied in HOA. Therefore, innovative topical pharmacological approaches greater than topical NSAIDs are awaited to treat HOA pain with a good safety profile.
The application of a topical corticosteroid, rather than a systemic one, could improve pain in inflammatory HOA, with a better benefit/risk profile. In 2023, betamethasone in optimized vehicle (Diprosone OV 0.05%) showed no superiority over control on pain and function in HOA. Noteworthy however, despite an anti-inflammatory effect, 1) the presence of synovitis was not required at inclusion for HOA patients while corticoids target inflammation and thus pain 2) Bethamethasone dipropionate (Diprosone) is not the most powerful dermocorticoid (class II)-3) Of the 4 levels of activity, clobetasol propionate 0.05% has the most powerful anti-inflammatory action (class I). The investigators hypothesize that topical clobetasol propionate 0.05% which has the most powerful anti-inflammatory action (class I) could reduce pain in patients with inflammatory HOA (defined by the presence of ≥2 clinical and ultrasound synovitis) with a good safety profile.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for enrollment, an individual must meet all of the following criteria.
- •Age ≥ 45 years
- •Symptomatic HOA according to the American College of Rheumatology criteria [10]
- •EVA ≥ 40/100 in the last 48 hours.
- •Presence of hand pain for at least 15 days in the last 30 days
- •At least ≥2 symptomatic IP joint with clinical palpable synovitis at inclusion.
- •Informed written consent
- •Prior treatment failure (inadequate response or intolerance to at least 1 recommended treatment among paracetamol, topical or oral NSAIDs, or short course of corticosteroids)
- •Patient affiliated to a social security scheme
排除标准
- •Patients will be excluded from participating in the study if they meet or are expected to meet any of the following criteria.
- •Isolated or predominant painful thumb-base OA (i.e., rhizarthrosis)
- •Other inflammatory joint disease (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)
- •Current skin abnormality, irritation, or lesions of the hands (e.g., eczema, urticarial lesion, skin infection) contraindicating topical application
- •Contraindication to propionate clobetasol
- •Existence of a pain syndrome of the upper limbs, which would interfere with the monitoring of pain
- •Fibromyalgia
- •Use of oral, intramuscular or intra-articular or intravenous steroids, other anti-synovial agents (e.g. slow-acting anti-rheumatic drugs such as methotrexate, sulfasalazine), intra-articular hyaluronic acid to the hand joints within the 1 month prior to the inclusion visit (W0)
- •Use of oral NSAIDs or paracetamol less than 48h before the inclusion visit (W0)
- •Any topical treatment (corticosteroids included) on treated extremities for any indication, other than cosmetic use of creams and lotions, within the 2 weeks prior to the inclusion visit (W0).
- •Any new hand OA treatment within the 2 months prior to the inclusion visit (W0), including physiotherapy and provision of new hand splint.
- •Use of opioids within the 4 weeks (or the equivalent of 5 half-lives) prior to the inclusion visit (W0)
- •Planned hand surgery in the next 6 weeks.
- •Use of any investigational (unlicensed) drug within the 3 months prior to the inclusion visit (W0).
- •History of glaucoma contraindicating the use of corticosteroids.
- •Presence of a serious, uncontrolled concomitant cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, neurological (including epilepsy) condition which, according to the investigator, makes the patient ineligible for the study.
- •Systemic progressive infection
- •Pregnant or breastfeeding woman
- •Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
- •Patient is unable to apply the study drug on hands
- •Participation in another interventional study or being in the exclusion period at the end of a previous study.
- •Patient on AME (state medical aid)
研究组 & 干预措施
Propionate de Clobétasol ( 0.05 %)
干预措施: Propionate de Clobétasol ( 0.05 %) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in pain intensity between W0 and W4
时间窗: Week 0- Week 4
Self-reported hand pain in the previous 48h measured on a 100 mm VAS at W0 and W4. The measurement will be done with the standard question recommended by Osteoarthritis Research Society International (OARSI)
次要结局
- Hand pain improvement(Week 0- week 4)
- Hand function at week 4(Week 0 - Week 4)
- Stiffness improvement at Week 4(Week 0 - Week 4)
- Treatment response and satisfaction at Week 4(Week 0 - Week 4)
- Quality of life improvement(Week 0 - Week 4)
- Safety assessment(Week2, Week4 and Week 8)
- Patient compliance(Week 0 -Week 04)