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Comparison of the Effectiveness of 10% Oxybutynin Topical Gel and 20% Aluminum Chloride in Patients with Primary Hyperhidrosis: a Randomized Double-Blind Controlled Trial

Protocol summary

Study aim
By Comparing the Effectiveness of Topical Oxybutynin Gel 10% and Aluminum Chloride 20% in Patients with Hyperhidrosis, It is Possible to Choose a More Effective Treatment method to Treat this Disease and Help Reduce the Complications Caused by This Disease.
Design
This Study is a Phase 4 Single-Blind Study That Includes 30 Patients. Patients are Individuals with Palmar and Axillary Hyperhidrosis Who Meet the Conditions for Entering the Study
Settings and conduct
A Double-Blind Clinical Trial With 30 Cases of Primary Hyperhidrosis Referred to Afzalipour Hospital, Kerman. Each Side of the Body, Were Randomly Treated with Drug a or b, Once a Day for two Months. At the Beginning and End of the Study, The Iodine-Starch Test, The Hyperhidrosis Severity Scale, Quality of Life Index, Severity of Complications and Rate of Patient Satisfaction Are Evaluated Through a Questionnaire. The Doctor Examining the Effectiveness of the Treatment are Not Aware of the Type of Treatment Performed on Both Sides of The Body
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with Primary Hyperhidrosis of the Palms and Axilla with Intensity 3 and Above and Aged 60-18 Exclusion Criteria: Iontophoresis, Botulinum Toxin Injection, Topical Antiperspirants، Sympathectomy In the Last 6 Months, Pregnant and Lactating Women, Secondary Hyperhidrosis, Sjogren or Sikka Syndrome, Allergy to Aluminum Salts
Intervention groups
This is a Split Study. One Side of The Patient's Body Is Treated with the First Drug and the Other Side is Treated with the Second Drug. One Container of Drug Contains the Topical Gel Contains 10% Oxybutynin and the Other One Contains 20% Aluminum Chloride
Main outcome variables
Severity of the disease, HDSS and DLQI Rating, Site of Involvement and Complications of the Disease

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221110056463N2
Registration date: 2023-06-13, 1402/03/23
Registration timing: retrospective

Last update: 2023-06-13, 1402/03/23
Update count: 0
Registration date
2023-06-13, 1402/03/23
Registrant information
Name
Najmeh Ahramianpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 370 3643
Email address
n.ahramianpour@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-21, 1401/08/30
Expected recruitment end date
2022-12-21, 1401/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of 10% Oxybutynin Topical Gel and 20% Aluminum Chloride in Patients with Primary Hyperhidrosis: a Randomized Double-Blind Controlled Trial
Public title
Comparison of the Effectiveness of 10% Oxybutynin Topical Gel and 20% Aluminum Chloride in Patients with Primary Hyperhidrosis: a Randomized Double-Blind Controlled Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
4
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7171791661
Approval date
2022-11-17, 1401/08/26
Ethics committee reference number
IR.KMU.AH.REC.1400.234

Health conditions studied

1

Description of health condition studied
Primary Hyperhidrosis
ICD-10 code
R61
ICD-10 code description
Generalized hyperhidrosis

Primary outcomes

1

Description
Severity of Hyperhidrosis
Timepoint
At the Beginning, Day 30 and 60
Method of measurement
Hyperhidrosis Disease Severity Scale Questionnaire

2

Description
Dermatology Quality of Life
Timepoint
At the Beginning, Day 30 and 60
Method of measurement
DLQI Questionnaire

3

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
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
Category
Treatment - Drugs

2

Description
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
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzalipour Hospital, Kerman
Full name of responsible person
Najmeh Ahramyanpour
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman,Iran
City
Kerman
Province
Kerman
Postal code
7171791661
Phone
+98 917 370 3643
Email
n.ahramianpour@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Najmeh Ahramyanpour
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7171791661
Phone
+98 34 3132 8237
Email
n.ahramianpour@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Najmeh Ahramyanpour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman,Iran
City
Kerman
Province
Kerman
Postal code
7171791661
Phone
0098341328237
Email
najmeh.pour@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Najmeh Ahramianpour
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7171791661
Phone
+98 917 370 3643
Fax
Email
n.ahramian@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Najmeh Ahramianpour
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Imam Khomeini Highway, Next to Shahid Bahonar University, Afzalipour Hospital, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7171791661
Phone
+98 917 370 3643
Fax
Email
n.ahramian@kmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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