A Phase 2 interventional study of Propionate de Clobétasol ( 0.05 %) and Placebo in Hand Osteoarthritis, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 2, Interventional, and Treatment
Among 13 studies in Osteoarthritis by Assistance Publique - Hôpitaux de Paris — 4 open to participants now, 4 under way, 1 of them phase 3. Osteoarthritis · Assistance Publique - Hôpitaux de Paris.
Among the 13 studies in Osteoarthritis by Assistance Publique - Hôpitaux de Paris, this one is the 2nd largest by planned enrollment of the 12 interventional ones, is one of 2 that started in 2026, is the only one in phase 2, and was the 13th registered.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 187 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →4 of the 13 studies in Osteoarthritis by Assistance Publique - Hôpitaux de Paris are open now, in 1 country. Each count lists the studies.
Of the 287 Osteoarthritis studies recruiting now, 158 (55%) set no upper age limit and 72 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.
This study: 45 Years and older · all sexes · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 2 started in 2026.
Median enrollment 112 across the 12 interventional studies, 50 across the 1 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
2 of the studies in Osteoarthritis by Assistance Publique - Hôpitaux de Paris that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06902805Phase 3Assistance Publique - Hôpitaux de ParisEfficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis. | 2027-05 |
| NCT07812701Assistance Publique - Hôpitaux de ParisTopical Clobetasol Propionate for Inflammatory Hand Osteoarthritis | 2026-11 |
Among the 13 studies in Osteoarthritis by Assistance Publique - Hôpitaux de Paris, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Symptomatic hand osteoarthritis (HOA) affects 8-16% of the $general population. It includes joint pain and functional disability, inducing a substantial daily burden.
Half of patients have an inflammatory HOA, characterized by the presence of synovitis at interphalangeal (IP) joint which is associated with an increased risk of pain (OR joint pain=2.4 IC95% (1.6-3.8)) and loss of function than in those without inflammatory HOA.
Systemic symptomatic pharmacological treatments of HOA are either poorly effective (ie, paracetamol) or tolerated (ie, oral non-steroidal anti-inflammatory drugs (NSAIDs)) in this elderly population. Studies evaluating systemic drugs (TNF or IL6 inhibitors) failed to show symptomatic efficacy in inflammatory HOA except for oral corticosteroids but with potential severe side effects.
In 2018, EULAR recommended topical treatments over systemic ones for safety issues. Topical NSAIDs are the 1st choice despite modest efficacy, with only 1 randomized placebo-controlled trial showing a significant but modest 7.2 mm difference over placebo on 0-100 mm visual analog scale (VAS) pain at week 4. Other topics such as capsaicin have not relevant efficacy or were not specifically studied in HOA. Therefore, innovative topical pharmacological approaches greater than topical NSAIDs are awaited to treat HOA pain with a good safety profile.
The application of a topical corticosteroid, rather than a systemic one, could improve pain in inflammatory HOA, with a better benefit/risk profile. In 2023, betamethasone in optimized vehicle (Diprosone OV 0.05%) showed no superiority over control on pain and function in HOA. Noteworthy however, despite an anti-inflammatory effect, 1) the presence of synovitis was not required at inclusion for HOA patients while corticoids target inflammation and thus pain 2) Bethamethasone dipropionate (Diprosone) is not the most powerful dermocorticoid (class II)-3) Of the 4 levels of activity, clobetasol propionate 0.05% has the most powerful anti-inflammatory action (class I). The investigators hypothesize that topical clobetasol propionate 0.05% which has the most powerful anti-inflammatory action (class I) could reduce pain in patients with inflammatory HOA (defined by the presence of ≥2 clinical and ultrasound synovitis) with a good safety profile.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible for enrollment, an individual must meet all of the following criteria.
Exclusion Criteria :
Patients will be excluded from participating in the study if they meet or are expected to meet any of the following criteria.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Propionate de Clobétasol ( 0.05 %)
Drug: Placebo
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.
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.
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
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
Quality of life improvement
Change between W0 and W4 in: * EQ-5D-5L index score (-0.53 to 1.00) and EQ VAS score (0-100) from the EQ-5D-5L questionnaire * EQ-5D-5L Global health status
Time frame: Week 0 - Week 4
Safety assessment
Proportion of side effects overall
Time frame: Week2, Week4 and Week 8
Patient compliance
Quantity of cream (g) used between W0 and W4 (indirectly assessed by the weight change of the cream tube).
Time frame: Week 0 -Week 04
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
Exploratory endpoint : Hand pain improvement
Change in pain intensity between W0 and W8 (W8-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 8
Exploratory endpoint : Hand pain improvement
Change in number of painful hand joints on pressure between W0 and W4 (W4-W0) and W0 and W8 (W8-W0) Joints will include 8 DIP, 10 PIP, 10 metacarpophaleangeal, 2 trapeziometacarpal joints.
Time frame: Week 0 - Week 8
Exploratory Outcome: Quality of life improvement at W8
Change between W0 and W8(W8-W0) in the following endpoints: * EQ-5D-5L index score (-0.53 to 1.00) and EQ VAS score (0-100) from the EQ-5D-5L questionnaire * Global health status using one question of the EQ\_5D\_5L questionnaire
Time frame: Week 0-Week 8
Exploratory Outcome: Treatment response at W8
* Proportion of patients responders according to the Patient global impression of change (PGIC) (0 no change or very much worsed to 7 considerable improvement, score 5 or 6 or 7 considered as "responders" versus score 1 to 4: non-responders) * Proportion of patients below the Patient Acceptable Symptom State of pain (VAS\<40/100) * Proportion of OMERACT-OARSI responders adapted to hand OA
Time frame: Week 0-Week 8
Treatment expectation and credibility at W0 and W4
-Difference in score of treatment expectation and credibility at W0 and W4
Time frame: Week 0-Week 4
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Nov 2026, 2 months later.
Of 82 phase 2 interventional studies under Osteoarthritis, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's planned 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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