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IRCT20140212016557N7 IRCT 2021-05-18 Shiraz University of Medical Sciences Effect of injection of methotrexate or triamcinolone in the nail for treatment of nail psoriasis Comparison of the effect of intralesional injection of methotrexate and triamcinolone in the treatment of nail psoriasis 2021-05-22 anticipated 78 Complete https://irct.ir/trial/56147 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants were randomized using permuted block randomization (size of each block: 4), in individual units, using random allocation software, Blinding description: Due to the difference of the drugs color and texture , the participants and principle investigator cannot be blind. But, data collector and outcome assessors are not aware of the medication of each case. 3 Nail psoriasis. Intervention 1: Intervention group: Intralesional injection of methotrexate (Mylan factory, France) is done in the nail matrix and bed every 3 weeks for 4 sessions. Intervention 2: Control group: Intralesional injection of triamcinolone (Iran-hormone factory, Iran) is done in the nail matrix and bed every 3 weeks for 4 sessions. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Possibility of loss of confidentiality
public Mozhdeh Sepaskhah
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134844119 +98 712125239 sepaskhah@sums.ac.ir Shiraz University of Medical Sciences scientific Mozhdeh Sepaskhah
Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134844119 +98 712125239 sepaskhah@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients between 16 and 70 years of age Clinically- or pathologically confirmed nail psoriasis that have involvement of one or more fingernails with psoriasis 16 years 70 years Both Patients with involvement of 5 or more nails Patients who received systemic or topical medication (for nail) in the last 3 months Patients with skin involvement of more than 20% that need systemic treatment Patients with nail fungal infection History of hypersensitivity reactions to lidocaine, triamcinolone, or methotrexate Diabetic patients Pregnancy Lactation Immunocompromised patients Patients with active peptic ulcer, gastritis, ascitis, and pleural effusion Concomitant use of hepatotoxic drugs, or drugs that interfere with methotrexate metabolism Concomitant radiotherapy Active or severe infection Decreased pulmonary function Renal failure L40.8 Other psoriasis Treatment - Drugs Treatment - Drugs Intervention group: Intralesional injection of methotrexate (Mylan factory, France) is done in the nail matrix and bed every 3 weeks for 4 sessions. Control group: Intralesional injection of triamcinolone (Iran-hormone factory, Iran) is done in the nail matrix and bed every 3 weeks for 4 sessions. Severity of nail involvement with psoriasis. Timepoint: At the beginning of treatment and weeks 3 ,6, 9, 12, 15, and 23. Method of measurement: modified Nail Psoriasis Severity Index (mNAPSI), measured by inspection and scoring of the severity of psoriasis features in nail matrix and bed. Pain severity during injection. Timepoint: At the beginning of treatment and weeks 3 ,6, 9, 12, 15, and 23. Method of measurement: illustrated numerical rating scale. Quality of life index. Timepoint: At the beginning and end of treatment. Method of measurement: Dermatology quality of life index questionnaire. Shiraz University of Medical Sciences Approved 2021-04-03 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand St., Shiraz. Iran Shiraz Fars Iran (Islamic Republic of)