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Topical Clobetasol Propionate for Inflammatory Hand osteoarthritis: A randomized trial versus placebo.(PROCLAME)
EU CTIS ID: 2025-520678-20-00
What this study is testing
To compare the efficacy on pain intensity between topical clobetasol propionate 0.05% with a tapering regimen (twice daily for 2 weeks followed by once daily for 2 weeks) versus placebo in patients with inflammatory hand osteoarthritis
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- •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
You likely can't join if
- •Isolated or predominant painful thumb-base OA (i.e., rhizarthrosis)
- •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.
See the full eligibility 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)
- •Isolated or predominant painful thumb-base OA (i.e., rhizarthrosis)
- •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
- •Other inflammatory joint disease (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)
- •Participation in another interventional study or being in the exclusion period at the end of a previous study.
- •Patient on AME (state medical aid)
- •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).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.