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Comparing the efficacy of azathioprine and mycophenolate mofetil in patients with sunlight induced dermatitis

A randomized controlled study to compare the efficacy of azathioprine and mycophenolate mofetil in patients of chronic actinic dermatitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038801
Enrollment
50
Registered
2021-12-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: L308- Other specified dermatitis

Interventions

Intervention1: Azathioprine: Azathioprine 50 mg once a day for initial 2 weeks followed by 2.5mg/kg/day in two divided doses for 12 weeks Control Intervention1: Mycophenolate mofetil: Mycophenolate mo

Sponsors

Post Graduate Institute of Medical Education and Research Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as chronic actinic dermatitis. 2. Age >18 years.

Exclusion criteria

Exclusion criteria: 1. Patients with hepatic/ renal disease/peptic ulcer disease. 2. Severe anaemia ( 3. Active infectious disease or immune system deficiency including AIDS. 4. Pregnant or lactating women. 5. Significant abnormalities in liver function (serum bilirubin, AST, ALT, and ALP > 1.5 times the upper limit of normal), viral hepatitis or cirrhosis. 6. H/o intolerance/hypersensitivity to azathioprine and/or mycophenolate mofetil.

Design outcomes

Primary

MeasureTime frame
·To compare the clinical and functional outcome after 3 months in each group, as assessed by EASI and DLQI. ·To compare the safety and tolerability of each drug by regular evaluation of clinical and biochemical parameters. Timepoint: Week 2, week 4, week 8, week 12

Secondary

MeasureTime frame
· Identification of the clinicodemographic factors predicting clinical outcome in each group.Timepoint: Baseline and week 12

Countries

India

Contacts

Public ContactSanjeev Handa

Post Graduate Institute of Medical Education and Research

handa_sanjeev@yahoo.com0172-2756564

Outcome results

None listed

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