Topical Clobetasol Propionate for Inflammatory Hand Osteoarthritis

ConditionHand Osteoarthritis

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age45+

SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Propionate de Clobétasol ( 0.05 %)
Drug
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
Drug
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.

Treatment groups

187 Participants

are divided into 2 treatment groups

Group A: Propionate de Clobétasol ( 0.05 %)Experimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change in pain intensity between W0 and W4

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)

Time frame

Week 0- Week 4

Secondary outcomes

Hand pain improvement

Change in pain intensity between W0 and W4 (W4-W0) of AUSCAN (Australian/Canadian Osteoarthritis Hand Index) pain subscore 0 = no difficulty 1. = mild difficulty 2. = moderate difficulty 3. = significant difficulty 4. = extreme difficulty

Time frame

Week 0- week 4

Hand function at week 4

Change between W0 and W4 (W4-W0) in the following endpoints: * AUSCAN (Australian/Canadian Osteoarthritis Hand Index), function subscore * Functional Index for Hand Osteoarthritis (FIHOA) score 0 = possible without difficulty 1. = possible with moderate difficulty 2. = possible with significant difficulty 3. = impossible

Time frame

Week 0 - Week 4

Stiffness improvement at Week 4

Change between W0 and W4 (W4-W0) in the following endpoints: \- AUSCAN, stiffness subscore 0 = no difficulty 1. = mild difficulty 2. = moderate difficulty 3. = significant difficulty 4. = extreme difficulty

Time frame

Week 0 - Week 4

Treatment response and satisfaction at Week 4

* Proportion of patients' responders according to the Patient global impression of change (PGIC) * Proportion of patients below the Patient Acceptable Symptom State of pain (VAS\<40/100) * Proportion of OMERACT-OARSI (Outcome Measures in Rheumatology - Osteoarthritis Research Society International ) responders adapted to hand OA

Time frame

Week 0 - Week 4

Other outcomes

Exploratory outcome: Consumption of paracetamol between W0 and W4

Mean daily paracetamol consumption (g/day), defined as total paracetamol consumption (g) divided by the total number of days of consumption from W0 to W4 using a patient self-reported notebook.

Time frame

Week 0-Week 04

Exploratory Outcome: Painful and swollen joints count between W0 and W4

Change painful and swollen joint count between W0 and W4 * Change in number of painful joint (joints will include 8 DIP, 10 PIP, 10 metacarpophalangeal, 2 trapeziometacarpal joints) between W0 and W4 * Change in number of swollen joint between W0 and W4

Time frame

Week 0-Week 04

Exploratory Outcome: Hand pain improvement

Change in pain intensity between W0 and W2 (W2-W0) of self-reported hand pain in the previous 48h measured on a 100 mm VAS (Visual Analog Scale) 0= no pain 100=the worst pain imaginable

Time frame

Week 0-Week 2

Exploratory endpoint : Hand pain improvement

Change in pain intensity between W0 and W8 (W8-W0) of self-reported hand pain in the previous 48h measured on a 100 mm VAS (Visual Analog Scale) 0= no pain 100=the worst pain imaginable

Time frame

Week 0 - Week 8

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov

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