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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Assistance Publique Hopitaux De Paris

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Decision date (initial)

2026-04-21

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To compare the efficacy on pain intensity between topical clobetasol propionate 0.05% with a tapering regimen (twice daily for 2 weeks followed by once daily for 2 weeks) versus placebo in patients with inflammatory hand osteoarthritis

Secondary objectives 2

1. To compare topical clobetasol proprionate 0.05% twice a day versus placebo for: Efficacy objectives 1.Hand pain improvement at W4 2.Hand function and stiffness improvement at W4 3.Treatment response at W4 4.Quality of life improvement at W4
2. To compare topical clobetasol proprionate 0.05% twice a day versus placebo for: Safety and compliance

Conditions and MedDRA coding

Adult patients with symptomatic and inflammatory Hand osteoarthritis HOA.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. •Age ≥ 45 years
2. •Symptomatic HOA according to the American College of Rheumatology criteria [10]
3. EVA ≥ 40/100 in the last 48 hours
4. •Presence of hand pain for at least 15 days in the last 30 days
5. •At least ≥2 symptomatic IP joint with clinical palpable synovitis at inclusion
6. •At least ≥2 IP joint with presence of moderate or major inflammation grey-scale synovitis (score 2 or 3) and/or Power Doppler signal (score ≥1) on ultrasound
7. •Informed written consent
8. •Patient affiliated to a social security scheme
9. Prior treatment failure (inadequate response or intolerance to at least 1 recommended treatment among paracetamol, topical or oral NSAIDs, or short course of corticosteroids)

Exclusion criteria 21

1. •Isolated or predominant painful thumb-base OA (i.e., rhizarthrosis)
2. •Other inflammatory joint disease (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)
3. •Current skin abnormality, irritation, or lesions of the hands (e.g., eczema, urticarial lesion, skin infection) contraindicating topical application
4. •Contraindication to propionate clobetasol
5. •Existence of a pain syndrome of the upper limbs, which would interfere with the monitoring of pain
6. •Fibromyalgia
7. •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)
8. •Use of oral NSAIDs or paracetamol less than 48h before the inclusion visit (W0)
9. •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).
10. •Any new hand OA treatment within the 2 months prior to the inclusion visit (W0), including physiotherapy and provision of new hand splint.
11. •Use of opioids within the 4 weeks (or the equivalent of 5 half-lives) prior to the inclusion visit (W0)
12. •Planned hand surgery in the next 6 weeks.
13. •Use of any investigational (unlicensed) drug within the 3 months prior to the inclusion visit (W0).
14. •History of glaucoma contraindicating the use of corticosteroids.
15. • 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.
16. •Systemic progressive infection
17. •Pregnant or breastfeeding woman
18. •Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
19. •Patient is unable to apply the study drug on hands
20. •Participation in another interventional study or being in the exclusion period at the end of a previous study.
21. •Patient on AME (state medical aid)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 1

1. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation

Assistance Publique Hopitaux De Paris

Address

Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux

City

Paris Cedex 10

Postcode

75475

Country

France

Scientific contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Dr Alice COURTIES

Public contact point

Organisation

Assistance Publique Hopitaux De Paris

Contact name

Sabrina AYADI

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications