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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
187
From D0-D28 a dose of cream (Clobetasol Propionate 0.05%) will be applied twice a day for 2 weeks then once a day for 2 weeks on painful joints with the maximum dose being the equivalent of a phalanx unit corresponding to the quantity of cream taken out of the tube and last deposited over the entire length of the phalanx of the index finger.
From D0-D28 a dose of cream (Placebo) will be applied twice a day for 2 weeks then once a day for 2 weeks on painful joints with the maximum dose being the equivalent of a phalanx unit corresponding to the quantity of cream taken out of the tube and last deposited over the entire length of the phalanx of the index finger.
Saint -Antoine Hospital_Rhumatology department
Paris, France
Change in pain intensity between W0 and W4
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)
Time frame: Week 0- Week 4
Hand pain improvement
Change in pain intensity between W0 and W4 (W4-W0) of AUSCAN (Australian/Canadian Osteoarthritis Hand Index) pain subscore 0 = no difficulty 1. = mild difficulty 2. = moderate difficulty 3. = significant difficulty 4. = extreme difficulty
Time frame: Week 0- week 4
Hand function at week 4
Change between W0 and W4 (W4-W0) in the following endpoints: * AUSCAN (Australian/Canadian Osteoarthritis Hand Index), function subscore * Functional Index for Hand Osteoarthritis (FIHOA) score 0 = possible without difficulty 1. = possible with moderate difficulty 2. = possible with significant difficulty 3. = impossible
Time frame: Week 0 - Week 4
Stiffness improvement at Week 4
Change between W0 and W4 (W4-W0) in the following endpoints: \- AUSCAN, stiffness subscore 0 = no difficulty 1. = mild difficulty 2. = moderate difficulty 3. = significant difficulty 4. = extreme difficulty
Time frame: Week 0 - Week 4
Treatment response and satisfaction at Week 4
* Proportion of patients' responders according to the Patient global impression of change (PGIC) * Proportion of patients below the Patient Acceptable Symptom State of pain (VAS\<40/100) * Proportion of OMERACT-OARSI (Outcome Measures in Rheumatology - Osteoarthritis Research Society International ) responders adapted to hand OA
Time frame: Week 0 - Week 4
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Quality of life improvement
Change between W0 and W4 in: * EQ-5D-5L index score (-0.53 to 1.00) and EQ VAS score (0-100) from the EQ-5D-5L questionnaire * EQ-5D-5L Global health status
Time frame: Week 0 - Week 4
Safety assessment
Proportion of side effects overall
Time frame: Week2, Week4 and Week 8
Patient compliance
Quantity of cream (g) used between W0 and W4 (indirectly assessed by the weight change of the cream tube).
Time frame: Week 0 -Week 04