CLOBETASOL PROPIONATE for Hand osteoarthritis

Inclusion criteria

• {"criterion_text":"-•Age ≥ 45 years"}
• {"criterion_text":"-•Symptomatic HOA according to the American College of Rheumatology criteria [10]"}
• {"criterion_text":"-EVA ≥ 40/100 in the last 48 hours"}
• {"criterion_text":"-•Presence of hand pain for at least 15 days in the last 30 days"}
• {"criterion_text":"-•At least ≥2 symptomatic IP joint with clinical palpable synovitis at inclusion"}
• {"criterion_text":"-•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"}
• {"criterion_text":"-•Informed written consent"}
• {"criterion_text":"-•Patient affiliated to a social security scheme"}
• {"criterion_text":"-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

• {"criterion_text":"-•Isolated or predominant painful thumb-base OA (i.e., rhizarthrosis)"}
• {"criterion_text":"-•Other inflammatory joint disease (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)"}
• {"criterion_text":"-•Current skin abnormality, irritation, or lesions of the hands (e.g., eczema, urticarial lesion, skin infection) contraindicating topical application"}
• {"criterion_text":"-•Contraindication to propionate clobetasol"}
• {"criterion_text":"-•Existence of a pain syndrome of the upper limbs, which would interfere with the monitoring of pain"}
• {"criterion_text":"-•Fibromyalgia"}
• {"criterion_text":"-•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)"}
• {"criterion_text":"-•Use of oral NSAIDs or paracetamol less than 48h before the inclusion visit (W0)"}
• {"criterion_text":"-•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)."}
• {"criterion_text":"-•Any new hand OA treatment within the 2 months prior to the inclusion visit (W0), including physiotherapy and provision of new hand splint."}
• {"criterion_text":"-•Use of opioids within the 4 weeks (or the equivalent of 5 half-lives) prior to the inclusion visit (W0)"}
• {"criterion_text":"-•Use of any investigational (unlicensed) drug within the 3 months prior to the inclusion visit (W0)."}
• {"criterion_text":"-•History of glaucoma contraindicating the use of corticosteroids."}
• {"criterion_text":"-\tPresence 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."}
• {"criterion_text":"-•Systemic progressive infection"}
• {"criterion_text":"-•Pregnant or breastfeeding woman"}
• {"criterion_text":"-•Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom"}
• {"criterion_text":"-•Patient is unable to apply the study drug on hands"}
• {"criterion_text":"-•Participation in another interventional study or being in the exclusion period at the end of a previous study."}
• {"criterion_text":"-•Patient on AME (state medical aid)"}
• {"criterion_text":"-•Planned hand surgery in the next 6 weeks."}

Primary endpoints

• {"endpoint_text":"-The primary endpoint is the change in pain intensity between W0 and W4 (W4-W0). 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): “how much pain in your hands did you experience during the last 48h?”.","definition_or_measurement_approach":"Change in self-reported hand pain between baseline (W0) and week 4 (W4); pain measured over the previous 48 hours using a 100 mm Visual Analogue Scale (VAS) with the standard OARSI question."}

Secondary endpoints

• {"endpoint_text":"-1.Hand Pain improvement: -Change in pain intensity between W0 and W4 (W4-W0) of AUSCAN pain subscore","definition_or_measurement_approach":"Change in AUSCAN pain subscore between W0 and W4 (W4-W0)."}
• {"endpoint_text":"-2.Hand function and stiffness improvement Change between W0 and W4 (W4-W0) in the following endpoints","definition_or_measurement_approach":"Change in AUSCAN function and stiffness subscore between W0 and W4 (W4-W0)."}
• {"endpoint_text":"-3.\tTreatment response at W4 -Proportion of patients’ responders according to the Patient global impression of change (PGIC)","definition_or_measurement_approach":"Proportion of responders at week 4 defined by Patient Global Impression of Change (PGIC)."}
• {"endpoint_text":"-4.Quality of life improvement -Change between W0 and W4 (W4-W0) in: EQ-5D-5L index score, EQ-5D-5L Global health status","definition_or_measurement_approach":"Change in EQ-5D-5L index score and EQ-5D-5L global health status between W0 and W4."}

France

Earliest CTIS Part Ii Submission Date

25-03-2026

Latest Decision Or Authorization Date

21-04-2026

Processing Time Days

27

Number Of Sites

13

Number Of Participants

187

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France