Back to resultsMethotrexate Iontophoresis Versus Coal Tar Ointement in the Treatment of Primary Palmer Hyper Hidrosis
Primary Purpose
Hyperhidrosis, Iontophore
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Iontophoresis with methotrexate
Iontophoresis with coal tar ointement
Sponsored by
About this trial
This is an interventional treatment trial for Hyperhidrosis
Eligibility Criteria
Inclusion Criteria: Patient with primary palmar hyperhidrosis to extend that their palms are wet during most of the day (score 3 and 4 in the Hyperhidrosis Disease Severity Scale) was included in this study. The palmer hyperhidrosis patient's age ranged from 15 to 35 years. All patients will be examined by dermatologist before starting the study. Exclusion Criteria: The study excluded the following patients: Patients with medical conditions that associated with hyperhidrosis are excluded, these conditions include:- hyperthyroidism, diabetes mellitus, parkinsonism, spinal cord injury, brain damage, congestive heart failure, anxiety, alcoholism and menopause. Patients who received any treatment with a drug that was affecting sweating e.g. (thyroxin, anxiolytics…..) that is not stopped at least 4 weeks preceding the study. Patients with cardiac conditions such as arrhythmia, ischemic heart disease, low exercise tolerance, low respiratory reserve were excluded. Patients, who have a local wound, sever eczema and severe fungal infection of the palms to minimize risk of local burn. Patients who have sensory disorders. Female patients who are pregnant and lactating.
Sites / Locations
- Outpatient clinic faculty of physical therapy cairo university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Methotreaxate iontophoresis
Coal tar ointment
Arm Description
Thirty patients of both sexes of primary palmar hyperhidrosis are selected to participate in this group from EL KASR EL- AINI
Thirty patients of both sexes of primary palmar hyperhidrosis are selected to participate in this group from EL KASR EL- AINI
Outcomes
Primary Outcome Measures
Assessing the change in Sweat output
Sweat output was objectively measured by recording mass gained by a standard diaper of approximately 30gm that was placed in contact with palms for 10 minutes and then was weighted using laboratory mass scale
Assessing the change in degree of severity of hyperhidrosis
By using Hyperhidrosis disease severity scale. It is a (4) points scale that is used to determine the degree of severity of hyperhidrosis
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05875285
Brief Title
Methotrexate Iontophoresis Versus Coal Tar Ointement in the Treatment of Primary Palmer Hyper Hidrosis
Official Title
Methotrexate Iontophoresis Versus Coal Tar Ointement in the Treatment of Primary Palmer Hyper Hidrosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
August 20, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to compare the therapeutic effect of methotrexate iontophoresis versus coal tar ointment on the the treatment of primary palmer hyperhidrosis?
Detailed Description
Some researchers stated that hyperhidrosis can render the skin susceptible to infection because of the continuous dampness of the skin. The condition may become socially, psychologically and professionally debilitating.
There are a lot of literatures concerned with studying the modalities used in the treatment of primary palmar hyperhidrosis, so this study will be conducted to compare between two of them and to show the best one for treating primary palmar hyperhidrosis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperhidrosis, Iontophore
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Methotreaxate iontophoresis
Arm Type
Experimental
Arm Description
Thirty patients of both sexes of primary palmar hyperhidrosis are selected to participate in this group from EL KASR EL- AINI
Arm Title
Coal tar ointment
Arm Type
Experimental
Arm Description
Thirty patients of both sexes of primary palmar hyperhidrosis are selected to participate in this group from EL KASR EL- AINI
Intervention Type
Other
Intervention Name(s)
Iontophoresis with methotrexate
Intervention Description
The methotrexate iontophoresis group the patient's hands are placed in direct contact with the conductive electrodes.
The patient will receive full explanation to the purpose of the treatment, the therapeutic and physiological benefits of this method of treatment. Before starting the treatment, all the previous measurements of each patient in this group is taken for a comparison.
Every patient will receive 12 sessions 3times/week every session consist of 30 minutes application of methotrexate iontophoresis using continuous direct current, the patient should feel mild tingling sensation (not painful), the polarity should be reversed halftime of treatment session, as the anodal current is more effective.
Intervention Type
Other
Intervention Name(s)
Iontophoresis with coal tar ointement
Intervention Description
For coal tar ointement group the ointement is putted direct on the skin after describing the instruction and method of application and time of application and do alarm instead not to forget.
Primary Outcome Measure Information:
Title
Assessing the change in Sweat output
Description
Sweat output was objectively measured by recording mass gained by a standard diaper of approximately 30gm that was placed in contact with palms for 10 minutes and then was weighted using laboratory mass scale
Time Frame
at baseline and after 4 weeks of intervention
Title
Assessing the change in degree of severity of hyperhidrosis
Description
By using Hyperhidrosis disease severity scale. It is a (4) points scale that is used to determine the degree of severity of hyperhidrosis
Time Frame
at baseline and after 4 weeks of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient with primary palmar hyperhidrosis to extend that their palms are wet during most of the day (score 3 and 4 in the Hyperhidrosis Disease Severity Scale) was included in this study.
The palmer hyperhidrosis patient's age ranged from 15 to 35 years.
All patients will be examined by dermatologist before starting the study.
Exclusion Criteria:
The study excluded the following patients:
Patients with medical conditions that associated with hyperhidrosis are excluded, these conditions include:- hyperthyroidism, diabetes mellitus, parkinsonism, spinal cord injury, brain damage, congestive heart failure, anxiety, alcoholism and menopause.
Patients who received any treatment with a drug that was affecting sweating e.g. (thyroxin, anxiolytics…..) that is not stopped at least 4 weeks preceding the study.
Patients with cardiac conditions such as arrhythmia, ischemic heart disease, low exercise tolerance, low respiratory reserve were excluded.
Patients, who have a local wound, sever eczema and severe fungal infection of the palms to minimize risk of local burn.
Patients who have sensory disorders.
Female patients who are pregnant and lactating.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nayera Radwan
Phone
+201000206016
Email
nayera.radwa55@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nayera Radwan
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Outpatient clinic faculty of physical therapy cairo university
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Methotrexate Iontophoresis Versus Coal Tar Ointement in the Treatment of Primary Palmer Hyper Hidrosis
We'll reach out to this number within 24 hrs