Topical Clobetasol Propionate for Inflammatory Hand Osteoarthritis

Trial details

Who runs it

Assistance Publique - Hôpitaux de Paris

Trial code

NCT07812701EU 2025-520678-20-00

Record updated

10 September 2026

Original description

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.Read full original descriptionShow less

Topical Clobetasol Propionate for Inflammatory Hand Osteoarthritis: A Randomized Trial Versus Placebo

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.

Inclusion: 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: 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); 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); 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; 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; 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; Existence of a pain syndrome of the upper limbs, which would interfere with the monitoring of pain; History of glaucoma contraindicating the use of corticosteroids; Systemic progressive infection; 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); Contraindication to propionate clobetasol; Fibromyalgia; Use of oral NSAIDs or paracetamol less than 48h before the inclusion visit (W0); Pregnant or breastfeeding woman; Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom; Patient on AME (state medical aid).

ClinicalTrials.gov NCT07812701 · EU CTIS 2025-520678-20-00