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IRCT20210822052255N1 IRCT 2021-09-28 Shiraz University of Medical Sciences Evaluation of local effect of Oxybutynin in treatment of palmar hyperhidrosis Determination and comparison of the effect of Oxybutynin in two forms of gel and nanoemulgel versus placebo in people with primary palmar hyperhidrosis 2021-09-23 anticipated 30 Complete https://irct.ir/trial/58313 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method was used for the two intervention groups and simple randomization method was used to choose the drug and placebo (left and right hand in each patient). A randomization table has been used for this purpose. The randomization table is attached to the proposal. Intergroup comparison between two intervention groups and intragroup comparison between each comparison group with its control group will be done. The advantage of using control group in each sample (intragroup comparison) in addition to reducing the sample size, is eliminating intergroup changes and thus increasing the accuracy of the comparison, Blinding description: The tubes containing Oxybutynin gel and placebo are identical and coded. The tubes allocated to each patient are labelled with the same patients of patient recruitment number. Care providor and investigator that deliver the gels are not involved in the outcome assessment. Type of drugs and which hand is being treated and which one is selected as the control remains unclear for both the patient and the outcome assessor until the end of the study. Therefore the research will be double-blinded. 3 Primary palmar hyperhidrosis. Intervention 1: Intervention group1: Simple 1% Oxybutynin gel is applied twice a day on the palm of a patient's hand for a month. Once at the beginning of the study and also after one month of taking the drug, the patient is visited. The drug is made by Dr. ُShohreh Alipour, a Pharmacologist colleague, PhD of Pharmaceutical Sciences, in the Pharmaceutics Laboratory of School of Pharmacy, Shiraz university of Medical Sciences. Intervention 2: Intervention group2: 1% Oxybutynin nanoemulgel is applied twice a day on the palm of a patient's hand for a month. Once at the beginning of the study and also after one month of taking the drug, the patient is visited. The drug is made by Dr. ُShohreh Alipour, a Pharmacologist colleague, PhD of Pharmaceutical Sciences, in the Pharmaceutics Laboratory of School of Pharmacy, Shiraz university of Medical Sciences. Intervention 3: Control group1: Gel base as the placebo is applied twice a day on the palm of the other patient's hand in both groups for a month. Once at the beginning of the study and also after one month of taking the drug, the patient is visited. The drug is made by Dr. ُShohreh Alipour, a Pharmacologist colleague, PhD of Pharmaceutical Sciences, in the Pharmaceutics Laboratory of School of Pharmacy, Shiraz university of Medical Sciences. 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 It is not yet known if there will be a plan to make this available
public Nasrin Saki
Dermatology Clinic, Faghihi Hospital, Zand St.
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3484 4119 Sakina@sums.ac.ir Shiraz University of Medical Sciences scientific Nasrin Saki
Dermatology clinic, Faghihi hospital, Zand St.
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3484 6316 Sakina@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Older than 18 years of age patients with primary palmar hyperhidrosis Patients should have ability to understand Persian language of written consent and questionnaire to participate in the study All topical and oral treatments should be discontinued for at least 4 weeks before beginning of the study, except for Botox injections, which should not have been injected in the past 12 weeks. 18 years no limit Both Reluctance to cooperate Hypersensitivity to topical Oxybutynin Pregnancy and lactation L74.512 Primary focal hyperhidrosis, palms Treatment - Drugs Treatment - Drugs Placebo Intervention group1: Simple 1% Oxybutynin gel is applied twice a day on the palm of a patient's hand for a month. Once at the beginning of the study and also after one month of taking the drug, the patient is visited. The drug is made by Dr. ُShohreh Alipour, a Pharmacologist colleague, PhD of Pharmaceutical Sciences, in the Pharmaceutics Laboratory of School of Pharmacy, Shiraz university of Medical Sciences. Intervention group2: 1% Oxybutynin nanoemulgel is applied twice a day on the palm of a patient's hand for a month. Once at the beginning of the study and also after one month of taking the drug, the patient is visited. The drug is made by Dr. ُShohreh Alipour, a Pharmacologist colleague, PhD of Pharmaceutical Sciences, in the Pharmaceutics Laboratory of School of Pharmacy, Shiraz university of Medical Sciences. Control group1: Gel base as the placebo is applied twice a day on the palm of the other patient's hand in both groups for a month. Once at the beginning of the study and also after one month of taking the drug, the patient is visited. The drug is made by Dr. ُShohreh Alipour, a Pharmacologist colleague, PhD of Pharmaceutical Sciences, in the Pharmaceutics Laboratory of School of Pharmacy, Shiraz university of Medical Sciences. Hyperhidrosis Disease Severity Index (HDSS). Timepoint: Before intervention and one month after starting intervention. Method of measurement: Hyperhidrosis Disease Severity Index (HDSS) score formula. Dermatology Life Quality Index (DLQI). Timepoint: Before intervention and one month after starting intervention. Method of measurement: Dermatology Life Quality Index (DLQI) formula score. Shiraz University of Medical Sciences Approved 2021-06-30 Ethics committee of Shiraz University of Medical Sciences Shiraz University of medical science, Zand Ave. Shiraz Fars Iran (Islamic Republic of)