Comparison the efficacy of Methotrexate with Immunace and Methotrexate alone on improvement of psoriasis vulgaris patients

Comparison the efficacy of Methotrexate with Immunace and Methotrexate alone on the clinical and immunological improvement of psoriasis vulgaris patients

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014012016275N1

Enrollment

Registered

2014-03-12

Start date

2014-01-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Psoriasis. Psoriasis vulgaris

Interventions

Intervention 1: Control group: Oral methotrexate 0.2- 0.4 mg/Kg until 8 weeks. Intervention 2: Intervention group: Oral methotrexate 0.2- 0.4 mg/Kg and Immunace capsule daily one capsule after launch,

Treatment - Drugs

Control group: Oral methotrexate 0.2- 0.4 mg/Kg until 8 weeks

Intervention group: Oral methotrexate 0.2- 0.4 mg/Kg and Immunace capsule daily one capsule after launch, until 8 weeks

Eligibility

Sex/Gender

All

Age

20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: New cases of psoriasis vulgaris (plaque) with 20% of body involvement who are new cases or don’t received systematic and or phototherapy treatment during the last 2 months; patients who complete the consent form and participate to study consciously. Exclusion criteria: Patients who want to leave the study with any reason; type one diabetes mellitus; pregnant or lactating women; patients below 20 years old; patients with familial hyperlipidemia; consumption of alcohol or alcoholic drink during study; variations in hepatic enzymes, fast blood sugar, lipid profile, cholesterol, CBC diff or ESR; any symptom which make patients to leave the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Psoriasis severity. Timepoint: Monthly until 8 weeks. Method of measurement: Psoriasis Severity Index (PASI) standard method.	—

Secondary

Measure	Time frame
Side effect. Timepoint: Monthly until the end of 8 weeks. Method of measurement: Variations of FBS, lipid profile, cholesterol, hepatic enzymes, CBC diff, ESR.;Cytokines Variations. Timepoint: Comparison baseline and terminal sample after the 8 weeks of treatment course. Method of measurement: Measuring selective cytokines by Real time PCR and Eliza method.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadis Yousefzadeh

Immunology Research Center

yousefzadehh901@mums.ac.ir+98 985117112611

Outcome results

None listed

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