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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520678-20-00

Enrollment

187

Registered

2026-04-21

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients with symptomatic and inflammatory Hand osteoarthritis HOA.

Brief summary

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?”.

Detailed description

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

Interventions

DRUGPlacebo de formule développée spécifiquement pour la recherche par la PUI (cf IMPD-Q)

DRUGCLOBETASOL PROPIONATE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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?”.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 22, 2026