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IRCT20160320027109N3 IRCT 2019-01-09 Shahid Beheshti University of Medical Sciences Effect of simvastatin in treatment of pachyonychia congenita Assessing the effectiveness of simvastatin in the treatment of patients with pachyonychia congenita: A crossover randomized controlled trial. 2019-01-01 anticipated 20 Complete https://irct.ir/trial/36132 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: Recruited patients are randomly allocated to either treatment or control arm. Both arms are in equal size. Randomization sequence is generated by Random Allocation Software version 1.0 May 2004, using a simple random method. It generates a randomization code for each participant (individual randomization). Randomization is run just one time at the beginning of the study. Then participants crossover based on the first randomized allocation. Sequentially numbered sealed opaque envelops are used to conceal the allocation. Each participant receives one envelope containing the randomization code, Blinding description: Blinding of the participants is achieved via administration of placebo which has the same package, figure, color, taste, smell, size, dosage, and route of administration as the drug used in the case group (simvastatin and the placebo are provided by the same company). In order to blind the outcome assessors, the researchers, and the data analyzers, simvastatin and placebo are referred to as A and B throughout the investigation. 2-3 Pachyonychia congenita. Intervention 1: Intervention group: Participants will be treated with simvastatin, given as a single oral dose of 40 mg in the evening. In patients aged 10 to 18 years, the treatment will be initiated with 20 mg of simvastatin. Before the beginning of the treatment and after 6 months on treatment, patients will be evaluated for the change in area and thickness of the lesions and indicators related to pain and quality of life. A biopsy specimen will be obtained both before and after the treatment to evaluate gene expression profiles. After a washout period of two months without treatment, patients will be assigned to the control group. Intervention 2: Control group:Participants will receive a single oral dose in the evening. Before the beginning of the treatment and after 6 months on treatment, patients will be evaluated for the change in area and thickness of the lesions and indicators related to pain and quality of life. A biopsy specimen will be obtained both before and after the treatment to evaluate gene expression profiles. After a washout period of two months without treatment, patients will be assigned to the control group. Yes - There is a plan to make this available What will be shared: It is not yet known if there will be a plan to make this available When: It is not yet known if there will be a plan to make this available To whom: It is not yet known if there will be a plan to make this available Conditions: It is not yet known if there will be a plan to make this available Where to obtain: It is not yet known if there will be a plan to make this available How to obtain: It is not yet known if there will be a plan to make this available Comments:
public Fateme Rajabi
The SBMU SRC (Skin Research Center),Shohada-E- Tajrish Educational Hospital,Qods Sq. ,Tehran, Iran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2274 1507 fatemarajabi@gmail.com Shahid Beheshti University of Medical Sciences scientific Fahimeh Abdollahimajd
The SBMU SRC (Skin Research Center),Shohada-E- Tajrish Educational Hospital,Qods Sq. ,Tehran, Iran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 2274 1507 fabdollahimajd@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) United States of America .Weight equal or more than 32kg Mentally healthy and able to clearly understand, assess, and respond questions. 10 years 65 years Both Cardiovascular disease. Renal impairment. Hepatic impairment or severe gastrointestinal disease. Diabetes. History of myopathy. Active fingernail and cutaneous cyst infection. If there is an infection in skin or fingernail, it must be treated before starting the trial. Pregnant or breastfeeding. History of hypersensitivity to statins. Previous consumption of statins for other reasons. History of drug or alcohol abuse. Q84.5 Enlarged and hypertrophic nails Treatment - Drugs Treatment - Drugs Intervention group: Participants will be treated with simvastatin, given as a single oral dose of 40 mg in the evening. In patients aged 10 to 18 years, the treatment will be initiated with 20 mg of simvastatin. Before the beginning of the treatment and after 6 months on treatment, patients will be evaluated for the change in area and thickness of the lesions and indicators related to pain and quality of life. A biopsy specimen will be obtained both before and after the treatment to evaluate gene expression profiles. After a washout period of two months without treatment, patients will be assigned to the control group. Control group:Participants will receive a single oral dose in the evening. Before the beginning of the treatment and after 6 months on treatment, patients will be evaluated for the change in area and thickness of the lesions and indicators related to pain and quality of life. A biopsy specimen will be obtained both before and after the treatment to evaluate gene expression profiles. After a washout period of two months without treatment, patients will be assigned to the control group. Area occupied by heperkeratotic lesions on palms and soles. Timepoint: At the beginning and end of each study phase. Method of measurement: Photography, imagej software. Plantar lesions maximum thickness. Timepoint: At the beginning and end of each study phase. Method of measurement: 20 MHz B mode Ultrasonography. Maximum nail thickness. Timepoint: At the beginning and end of each study phase. Method of measurement: 20 MHz B mode Ultrasonography. Self-report nail grooming need. Timepoint: At the beginning and end of each study phase. Method of measurement: Likert scale. Self-report hyperkeratotic lesion grooming need. Timepoint: At the beginning and end of each study phase. Method of measurement: Likert scale. Physicians satisfaction with patients response. Timepoint: At the beginning and end of each study phase. Method of measurement: Likert scale. Patients mobility,treadmill tolerance test. Timepoint: At the beginning and end of each study phase. Method of measurement: The maximum time a patient could tolerate walking a on a treadmill. Mcgill pain questionnaire. Timepoint: At the beginning and end of each study phase. Method of measurement: Questionnaire. Dermatology Life Quality Index (DLQI). Timepoint: At the beginning and end of each study phase. Method of measurement: Questionnaire. Keratin gene expression. KRT 6a, 6b, 6c, 16, 17. Timepoint: At the beginning and end of each study phase. Method of measurement: Histophatologic evluation. Simvastatin side-effects. Timepoint: Throughout the treatment. Method of measurement: Any exacerbation of clinical signs or laboratory changes. Patient compliance with medication. Timepoint: Throughout the treatment. Method of measurement: According to physicians estimates, Likert scale. Shahid Beheshti University of Medical Sciences Approved 2018-12-09 Ethics committee of Skin Research Center Shahid Beheshti University of Medical Sciences The SBMU SRC (Skin Research Center),Shohada-E- Tajrish Educational Hospital,Qods Sq. ,Tehran, Iran Tehran Tehran Iran (Islamic Republic of)