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

Not Applicable

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

Registration Number: CTRI/2024/07/071447

Lead Sponsor: IMS and SUM Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in <br/ ><br>Investigator global assessment score for chronic nodular prurigo <br/ ><br>Worst itch numerical rating score(WI -NRS) <br/ ><br>DLQI, <br/ ><br>Dermoscopic evaluation <br/ ><br>Photographic evaluation <br/ ><br>Timepoint: 4 weekly <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Improvement in Disease life quality index will be assessed in both groups <br/ ><br> <br/ ><br>Timepoint: Assessment will be done 4weekly during followup