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A clinical trial to Study the effects of oral tofacitinib and azathioprine in chronic actinic dermatitis

Study of efficacy and safety of oral tofacitinib vs azathioprine in the management of chronic actinic dermatitis-An open randomised clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/051181
Enrollment
36
Registered
2023-03-29
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

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

Conditions

Health Condition 1: L562- Photocontact dermatitis [berloquedermatitis]

Interventions

Intervention1: Tablet Tofacitinib: Group B (18 patients) will be given Tablet Tofacitinib 5mg twice daily orally for 3months.The first and second follow up will be conducted after 15 days and 30 days

Sponsors

Krishna Vishwa Vidyapeeth
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with Clinical diagnosis of chronic actinic dermatitis including: Actinic Prurigo Actinic cheilitis Lichenoid photodermatitis Photoallergic dermatitis Phytophotodermatitis Actinic reticuloid 2. Age group more than 18 years of age. 3. The patient should have given written consent before the investigations and starting the drug. 4. The patient should be able and willing and fit, in the view of the investigator, to comply with all study procedures

Exclusion criteria

Exclusion criteria: A .Patients with acute photodermatitis. B. Patients allergic to tofacitinib or azathioprine. C. Patient with cardiac diseases or hematological diseases (including angina, coronary artery disease, recent or acute myocardial infarction, pericardial effusion,anemia,coagulation disorders) D. Patients with cerebrovascular diseases E.Patients with deranged liver and kidney function. F. Patients with recent infections. G. Patient with positive mantoux test. H.Patients with a recent or past history of tuberculosis I.Patient with a positive Interferon Gamma Release Assay (IGRA) test. J.Patients with a history of acute phototoxic diseases. K.Phototoxic rash related to some drug. L.Patients with Low Thiopurine Methyl Transferase(TPMT) value ( O.Patients having diabetes mellitus. P.Patients with any immunocompromised conditions.

Design outcomes

Primary

MeasureTime frame
To compare the efficacy and safety of oral tofacitinib with azathioprine in chronic actinic dermatitisTimepoint: At baseline,15 days,30 days,2 months and 3 months.

Secondary

MeasureTime frame
Not applicableTimepoint: Not applicable

Countries

India

Contacts

Public ContactBalkrishna Nikam

Krishna Vishwa Vidyapeeth

mangeshnikam@yahoo.com9322373096

Outcome results

None listed

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