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Clinical Trials in the EU / 2025-520678-20-00
Authorised, not yet recruiting Phase III

Topical Clobetasol Propionate for Inflammatory Hand osteoarthritis: A randomized trial versus placebo.(PROCLAME)

2025-520678-20-00 · tracked via the Priya Life Science EU tracker
Sponsor
Assistance Publique Hopitaux De Paris
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Musculoskeletal Diseases
Decision date
07/08/2026
Enrollment target
187
Sites
France

Condition studied

Adult patients with symptomatic and inflammatory Hand osteoarthritis HOA.

Investigational medicinal product(s)

Placebo de formule développée spécifiquement pour la recherche par la PUI (cf IMPD-Q)CLOBETASOL PROPIONATE

Every trial of Clobetasol Propionate across our registers →

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

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?”.

Endpoint detail

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

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-520678-20-00 on CTIS ↗ ← All trials in the EU