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Evaluation of regulatory T cell and disease activity after transdermal administration of Dovonex(r) ointment 50ug/g in patients with rheumatoid arthritis

Evaluation of regulatory T cell and disease activity after transdermal administration of Dovonex(r) ointment 50ug/g in patients with rheumatoid arthritis - Evaluation of regulatory T cell and disease activity after transdermal administration of Dovonex(r) ointment 50ug/g in patients with rheumatoid arthritis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000022296
Enrollment
20
Registered
2016-05-15
Start date
2016-05-30
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Rheumatoid arthritis

Interventions

Transdermal administration of 5g of Dovonex(r) ointment 50ug/g twice daily for 7 days. 7 days administration and following 7 days wash-out period are repeated twice.

Sponsors

Medical Co.LTA PS Clinic
Lead Sponsor
Medical Co.LTA PS Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1, Patients with rheumatoid arthritis diagnosed based on either ACR 1987 revised criteria or 2010 ACR/EULAR Classification Criteria for Rheumatoid Arthritis. 2, Patients currently treated with antirheumatic drug (except for Cyclosporine and Tacrolimus) 3, 20 years of age or older at the time of consent. 4, Patients who are not during pregnancy or lactation. 5, Patients who consented in writing prior to the commencement of the study procedure.

Exclusion criteria

Exclusion criteria: 1, Patients with other systemic autoimmune disease (e.g. systemic erythematosus). 2, Patients with history of hypersensitivity to Calcipotriol. 3, Patients with or with the risk of hypercalcemia, or whose serum calcium level exceed normal range. 4, Patients currently treated with Calcineurin antagonist (Cyclosporine or Tacrolimus). 5, Patients currently treated with anti-osteoporosis drugs (Vitamin D3, PTH). 6, Patients whose eGFR is 60 or lower. 7, Patients treated for bacterial infection within 30 days prior to the first administration of the study drug. 8, Uncooperative patients who might not comply with the protocol procedure. 9, Patients with malignant tumor requiring treatment within past 5 years. 10, Patients judged inappropriate for this study by principal investigator.

Design outcomes

Primary

MeasureTime frame
The change of Treg are evaluated before and 8 days after transermal administration of Dovonex(r) ointment 50ug/g.

Secondary

MeasureTime frame
Evaluate change in disease activity using RA activity indexes

Countries

Japan

Contacts

Public ContactMIDORI SUZAKI

Medical Co.LTA PS Clinic Nurse

midori-suzaki@lta-med.com0922837777

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026