Starting soon
Phase 2
Topical Clobetasol Propionate for Inflammatory Hand Osteoarthritis
Condition(s) studied
Hand Osteoarthritis
Investigational drug(s) / intervention(s)
Propionate de Clobétasol ( 0.05 %)Placebo
Propionate de Clobétasol ( 0.05 %): 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.
Placebo: 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.
Study summary
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.
Eligibility
Inclusion Criteria:
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
Exclusion Criteria :
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)
Primary outcome measure(s)
- Change in pain intensity between W0 and W4 — 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)
Trial sites (1)
| Facility | City | Region | Status |
| Saint -Antoine Hospital_Rhumatology department |
Paris |
France |
|
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