Hand OsteoarthritisPhase 2PROCLAMENCT07812701
Topical Clobetasol Propionate for Inflammatory Hand Osteoarthritis
A Phase 2 study testing Propionate de Clobétasol ( 0.05 %) in people with Hand Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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 more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Propionate de Clobétasol ( 0.05 %)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
- 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
- Existence of a pain syndrome of the upper limbs, which would interfere with the monitoring of pain
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- Fibromyalgia
- 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)
- Use of oral NSAIDs or paracetamol less than 48h before 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).
- History of glaucoma contraindicating the use of corticosteroids.
- 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.
- Systemic progressive infection
- Pregnant or breastfeeding woman
- Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
- 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.
- Patient on AME (state medical aid)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Saint -Antoine Hospital_Rhumatology department
Paris, 75012
Alice COURTIES, MD, +33149283360, alice.courties@aphp.fr
Jérémie SELLAM, MD, +33149282520, jeremie.sellam@aphp.fr
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Hand Osteoarthritis
- Being tested
- Propionate de Clobétasol ( 0.05 %), Placebo
- Keywords
- Symptomatic hand osteoarthritis (HOA), Clobetasol propionate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Propionate de Clobétasol ( 0.05 %) | Experimental | Not described Receives: Drug: Propionate de Clobétasol ( 0.05 %) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Week 0- Week 4
Secondary outcomes (7)
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
- = mild difficulty
- = moderate difficulty
- = significant difficulty
- = extreme difficulty
Measured: 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
- = possible with moderate difficulty
- = possible with significant difficulty
- = impossible
Measured: 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
- = mild difficulty
- = moderate difficulty
- = significant difficulty
- = extreme difficulty
Measured: 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
Measured: 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
Measured: Week 0 - Week 4
Safety assessment
Proportion of side effects overall
Measured: 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).
Measured: Week 0 -Week 04
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 187 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alice COURTIES, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812701
- Sponsor's protocol ID
- APHP240804
- Other IDs
- 2025-520678-20-00, 2025
- Acronym
- PROCLAME
- Status last verified
- Sep 2026
- First submitted
- 10 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Clobetasol Propionate for Inflammatory Hand Osteoarthritis: A Randomized Trial Versus Placebo
- ClinicalTrials.gov ID
- NCT07812701
- Acronym / sponsor ID
- PROCLAME / APHP240804
- Conditions
- Hand Osteoarthritis
- Keywords
- Symptomatic hand osteoarthritis (HOA), Clobetasol propionate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 187 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propionate de Clobétasol ( 0.05 %) | Experimental | Drug: Propionate de Clobétasol ( 0.05 %) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (22 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Propionate de Clobétasol ( 0.05 %)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. | Drug | Propionate de Clobétasol ( 0.05 %) |
| PlaceboFrom 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. | Drug | Placebo |
Primary outcome
Change in pain intensity between W0 and W4
Time frame: Week 0- Week 4
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)
7 secondary outcomes
Hand pain improvement
Time frame: Week 0- week 4
Hand function at week 4
Time frame: Week 0 - Week 4
Stiffness improvement at Week 4
Time frame: Week 0 - Week 4
Treatment response and satisfaction at Week 4
Time frame: Week 0 - Week 4
Quality of life improvement
Time frame: Week 0 - Week 4
Safety assessment
Time frame: Week2, Week4 and Week 8
Patient compliance
Time frame: Week 0 -Week 04
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alice COURTIES, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propionate de Clobétasol ( 0.05 %) in people with Hand Osteoarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice COURTIES, MD (+33149283360, alice.courties@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity between W0 and W4 (time frame: Week 0- Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.