Efficacy and Safety of Topical Clobetasol Propionate versus Placebo in Adult Patients with Inflammatory Hand Osteoarthritis: A Randomized Controlled Trial
- Trial ID
- 2025-520678-20-00
- Protocol
- APHP240804
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate the efficacy of topical clobetasol propionate 0.05% using a tapering regimen compared to a placebo regarding pain intensity in patients with hand osteoarthritis. Secondary objectives include the assessment of the following at week 4:
- Improvement in hand pain
- Improvement in hand function and stiffness
- Treatment response
- Improvement in quality of life
- Safety and compliance
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of adult patients, including both males and females, diagnosed with symptomatic and inflammatory hand osteoarthritis. Eligible participants are aged 45 years or older and meet the American College of Rheumatology criteria for the condition. Clinical requirements include a minimum visual analogue scale score of 40/100 within the previous 48 hours and the presence of hand pain for at least 15 days during the preceding month. Additionally, subjects must exhibit at least two symptomatic interphalangeal joints with clinical synovitis and specific ultrasound findings, such as grey-scale synovitis or a Power Doppler signal. Inclusion also requires a history of treatment failure involving paracetamol, non-steroidal anti-inflammatory drugs, or short-course corticosteroids.
Plans and Procedures
This phase IIIb, randomized, double-blind, placebo-controlled trial is designed to compare the efficacy of topical clobetasol propionate 0.05% against a placebo in patients diagnosed with hand osteoarthritis exhibiting inflammatory symptoms. The study utilizes a tapering regimen for the active treatment, consisting of twice-daily applications for two weeks followed by once-daily applications for two weeks. The research methodology focuses on evaluating the change in pain intensity, measured via a 100 mm visual analogue scale (VAS), between the baseline visit and the four-week follow-up. Secondary endpoints include improvements in hand function, stiffness, treatment response according to the patient global impression of change, and quality of life assessed through the EQ-5D-5L index. Participant involvement encompasses a screening period to confirm inclusion criteria—such as age 45 years or older, specific synovitis clinical markers via ultrasound, and prior treatment failure—followed by the active treatment phase and an end-of-study assessment at week 4.
Treatment
The experimental treatment consists of clobetasol propionate administered via cutaneous use. The medication is applied using a tapering regimen, which involves application twice daily for a duration of 2 weeks, followed by once daily for an additional 2 weeks.
A placebo, specifically formulated for research purposes, is utilized as a comparator treatment in this study of inflammatory hand osteoarthritis.
Efficacy
The efficacy of topical clobetasol propionate in patients with hand osteoarthritis will be evaluated through several parameters. The primary endpoint is the change in pain intensity from baseline (W0) to week 4 (W4). This assessment is based on self-reported hand pain experienced during the previous 48 hours, measured using a visual analogue scale (VAS) of 100 mm according to the standard question recommended by the Osteoarthritis Research Society International (OARSI).
Secondary endpoints include the following assessments conducted between W0 and W4:
- Improvement in hand pain as measured by the AUSCAN pain subscore.
- Changes in hand function and stiffness.
- Treatment response at W4, defined as the proportion of responders according to the patient global impression of change (PGIC).
- Improvements in quality of life, assessed via the EQ-5D-5L index score and global health status.
Inclusion and Exclusion Criteria
Inclusion 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
- •At least ≥2 IP joint with presence of moderate or major inflammation grey-scale synovitis (score 2 or 3) and/or Power Doppler signal (score ≥1) on ultrasound
- •Informed written consent
- •Patient affiliated to a social security scheme
- Prior treatment failure (inadequate response or intolerance to at least 1 recommended treatment among paracetamol, topical or oral NSAIDs, or short course of corticosteroids)
Exclusion 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)
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 France | Not Yet Recruiting | 01 Apr 2026 | 187 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Placebo de formule développée spécifiquement pour la recherche par la PUIcf IMPD-Q | Placebo | N/A | — | — | — | N/A |
CLOBETASOL PROPIONATE | Test | — | CUTANEOUS USE | 1 | 30 | SUB01346MIG |