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Comparing low dose apremilast with low dose tofacitinib in the treatment of mild to moderate chronic plaque psoriasis

Comparing low dose apremilast with low dose tofacitinib in the treatment of mild to moderate chronic plaque psoriasis: A randomized open label prospective active controlled non-inferiority study. - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073724
Enrollment
64
Registered
2024-09-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Health Condition 1: L40- Psoriasis

Interventions

Intervention1: drugs - Tofacitinib: group B will recieve Tofacitinib 5 mg OD Control Intervention1: drugs - apremilast: group A will recieve apremilast 30 mg OD

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosis: Chronic plaque psoriasis patient with active disease of duration of more than one year. Body surface area (BSA) involvement is less than 10%. Participants must be adult (18 years or older) of any sex, presenting to the Dermatology OPD. Participants providing written informed consent.

Exclusion criteria

Exclusion criteria: Patients unwilling to give written informed consent to participate in the study. Patients of Psoriasis with other major dermatological ailments (Immunobullous disease, SLE, Connective tissue diseases, Autoimmune diseases, Vitiligo, Vasculitis). Patients with underlying hepatic, renal diseases, coronary artery disease (CAD) or any major contraindications to the use of tofacitinib or apremilast. Pregnant, lactating females. Patient who are currently receiving or have received other systemic medication for the treatment of psoriasis in the past 3 months.

Design outcomes

Primary

MeasureTime frame
Overall effective rate: Number of patients achieving PASI 75 at the end of treatment (12 weeks) within group A and B/Total number of patients.Timepoint: 12 weeks

Secondary

MeasureTime frame
PASI,DLQI scores will be reviewed 4 weekly (0, 4, 8, 12, 16, 20, 24). sPGA, PSS scores will be recorded before & after treatment (12 weeks) & follow-up at 24 weeks. sPGA, PSS scores will be recorded before & after treatment (12 weeks) & follow-up at 24 weeks.Timepoint: baseline 0 week, 4 weeks, 8 weeks , 12weeks , 16 weeks , 20 weeks , 24 weeks

Countries

India

Contacts

Public Contactpurva

AIIMS Rajkot

yashdeepsinghpathania@gmail.com8860762930

Outcome results

None listed

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