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IRCT20221110056463N2 IRCT 2023-06-13 Kerman University of Medical Sciences Comparison of the Effectiveness of 10% Oxybutynin Topical Gel and 20% Aluminum Chloride in Patients with Primary Hyperhidrosis: a Randomized Double-Blind Controlled Trial Comparison of the Effectiveness of 10% Oxybutynin Topical Gel and 20% Aluminum Chloride in Patients with Primary Hyperhidrosis: a Randomized Double-Blind Controlled Trial 2022-11-21 anticipated 30 Complete https://irct.ir/trial/66869 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Blinding description: The Study is Single-Blind. In this Way: The Person Evaluating the Outcome Does Not Have any Information About the Content of the Drug Used in Each Side and only Checks the Effectiveness of Each Side and Compares it With the Other Side. 4 Primary Hyperhidrosis. Intervention 1: Intervention Group: The First Group: A Patient with Hyperhidrosis of the Palm or Axilla, Is Treated with a Topical Gel Containing 10% Oxybutynin on One Side of the Body. It is Explained to the Patient That at Night, 1 cm of the Gel Should Be Applied on the Clean and Dry Skin of the Same Side and It Should Not be Washed For 4 Hours after Use. Use and In the Next 30 Days Reduce It to Once Every Other Night. Intervention 2: Intervention group: The second group: a patient with hyperhidrosis of the palm or axilla, is treated with a topical gel containing 20% aluminum chloride on the other side of the body. It is explained to the patient that at night, 1 cm of the gel should be applied on the clean and dry skin of the same side and it should not be washed for 4 hours after use. use and in the next 30 days reduce it to once every other night. 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 we will decide at the end of the study
public Najmeh Ahramyanpour
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman,Iran
Kerman Iran (Islamic Republic of) 7171791661 0098341328237 najmeh.pour@gmail.com Kerman University of Medical Sciences scientific Najmeh Ahramianpour
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
Kerman Iran (Islamic Republic of) 7171791661 +98 917 370 3643 n.ahramian@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Primary Excessive Sweating with a Score of 3 or Higher on the Hyperhidrosis Disease Severity Scale (HDSS), at Least in the last 6 Months No Treatment during 6 Months before Entering the Study with Iontophoresis, Botulinum Toxin Injection no Performance of Sympathectomy 18 years 60 years Both Pregnant and Lactating Women People who have Secondary Excessive Sweating due to an External Factor People with Active Skin Disease such as: Psoriasis, Eczema, Seborrhea and Skin Infection, Glaucoma, Urinary Retention, Myasthenia Gravis, Sjögren's Syndrome or Sicca Syndrome History of Allergy to Aluminum Salts R61 Generalized hyperhidrosis Treatment - Drugs Treatment - Drugs Intervention Group: The First Group: A Patient with Hyperhidrosis of the Palm or Axilla, Is Treated with a Topical Gel Containing 10% Oxybutynin on One Side of the Body. It is Explained to the Patient That at Night, 1 cm of the Gel Should Be Applied on the Clean and Dry Skin of the Same Side and It Should Not be Washed For 4 Hours after Use. Use and In the Next 30 Days Reduce It to Once Every Other Night Intervention group: The second group: a patient with hyperhidrosis of the palm or axilla, is treated with a topical gel containing 20% aluminum chloride on the other side of the body. It is explained to the patient that at night, 1 cm of the gel should be applied on the clean and dry skin of the same side and it should not be washed for 4 hours after use. use and in the next 30 days reduce it to once every other night Severity of Hyperhidrosis. Timepoint: At the Beginning, Day 30 and 60. Method of measurement: Hyperhidrosis Disease Severity Scale Questionnaire. Dermatology Quality of Life. Timepoint: At the Beginning, Day 30 and 60. Method of measurement: DLQI Questionnaire. Severity of Complications. Timepoint: At the Beginning of the Study and Day 30 and 60. Method of measurement: A self-Made Questionnaire with a Score of 0-2 to Check the Severity of the Complication. Kerman University of Medical Sciences Approved 2022-11-17 Ethics committee of Kerman University of Medical Sciences Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran Kerman Kerman Iran (Islamic Republic of)