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Comparing effectiveness of oral Tofacitinib versus oral Cyclosporine in the treatment of prurigo nodularis

Comparison betwwen effectiveness of oral Tofacitinib Vs oral Cyclosporine in the treatment of prurigo nodularis: An accessor-blinded randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071447
Enrollment
58
Registered
2024-07-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Health Condition 1: L281- Prurigo nodularis Health Condition 2: L281- Prurigo nodularis

Interventions

Intervention1: Cyclosporine: The patients meeting all the inclusion criteria will participate in this study A detailed history including the duration of disease, associated medical conditions, treatm

Sponsors

IMS and SUM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with more than equal to 18 years age group, diagnosed clinically and histopathologically as prurigo nodularis and having with severe pruritus for at least 3 months Severe pruritus was defined as a mean score of at least 7 points over the previous week for the worst daily intensity of pruritus on the numerical rating scale Patients having an active health insurance.

Exclusion criteria

Exclusion criteria: 1. chronic pruritus due to conditions other than PN; 2. use of antihistamines, steroids, other systemic antipruritic therapies, or immunosuppressants 1 to 2 weeks before the baseline visit; 3. recent phototherapy; 4. use of medications known to induce pruritus; serum creatinine level higher than 2.4 mg/dL; 5. aspartate transaminase or alanine transaminase levels more than 2 times the upper limit of normal; 6. Active infection(HIV, Tuberculosis, Hepatitis b,etc) 7. Latent tuberculosis 8. Known case of dyslipidemia 9. Prior history of MI, cerebral ischaemia and transient ischaemic attack. 10. History of prior venous thromboembolism, major surgery and immobolisation in past 6 months. 11. On concurrent oral contraceptive pills or hormone replacement therapy. 12. Patient have any inherited coagulation disorder. 13. Pregnant and lactating females

Design outcomes

Primary

MeasureTime frame
Improvement in Investigator global assessment score for chronic nodular prurigo Worst itch numerical rating score(WI -NRS) DLQI, Dermoscopic evaluation Photographic evaluation Timepoint: 4 weekly

Secondary

MeasureTime frame
Improvement in Disease life quality index will be assessed in both groups Timepoint: Assessment will be done 4weekly during followup

Countries

India

Contacts

Public ContactSubhasree Madhual

IMS AND SUM HOSPITAL

subhasreemadhual@gmail.com8249642701

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026