Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: Topical methotrexate gel
: Topical methotrexate gel 1%
Participants will be provided, topical methotrexate gel and each patient will be instructed to apply a very thin film of 0.5 ml of
Sponsors
Jennifer Monica Asirvatham
Eligibility
Inclusion criteria
Inclusion criteria: 1)Bilateral mild -moderate palmoplantar psoriasis. 2)Patient is 18 years of age or older 3)Both sexes 4)Patients must be able and willing to provide written informed consent and comply with the requirements of this study protocol 5)Patient willing for regular follow up 6)Female patients of childbearing potential must have a negative serum pregnancy test at the Screening visit.
Exclusion criteria
Exclusion criteria: 1)Psoriasis covering >10% of other body surface. 2)Haematological & hepatic disorder patients. 3)Patient is pregnant, breastfeeding, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter. 4)Patient who has used any topical treatment for psoriasis (except non-medicated emollients) in the last 2 weeks before Day 0 with the exception of shampoos containing tar, salicylic acid or zinc pyrithione. 5)Patient who has used UVB phototherapy or excessive sun exposure less than 14 days before Day 0. 6)Patient who have used any biological therapy for the treatment of psoriasis less than 90 days before day 0. 7)Patient has used any non-biological systemic therapy for the treatment of psoriasis (including PUVA therapy), systemic steroids or systemic immunosuppressants less than 28 days before Day 0. Investigational non-biologics agents must be discontinued at least 28 days or 5 half-lives prior to Day 0 (whichever is longer). 8)Patient is taking or requires oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed. Patients who have used oral or injectable corticosteroids less than 28 days before Day 0 are excluded 9)Patient is currently participating in a clinical trial with an experimental drug or device.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of topical Methotrexate gel 1% & topical Betamethasone valerate 0.1% in treatment of palmoplantar psoriasis using salicylic acid as the surfactant for enhancing percutaneous delivery of methotrexate. Timepoint: Comparison of change in Psoriasis Area & Severity Index (PASI) from baseline to 8 week. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of adverse events occurring with Betamethasone valerate & methotrexate.Timepoint: Comparison of change in erythema, fissuring & scaling between the study groups at the end of 2nd,4th,6th & 8th week. Comparison of change in Mean Percent Palmoplantar Psoriasis Surface Area (PPSA) between Betamethasone valerate & methotrexate from baseline to 8 week. Comparison of adverse events occurring with Betamethasone valerate & methotrexate from baseline to 8 week. | — |
Countries
India
Contacts
Public ContactJennifer Monica Asirvatham
Professor and Head of the department of pharmacology Sri Ramachandra Medical College
Outcome results
None listed