Methotrexate Iontophoresis Versus Coal Tar Ointement in the Treatment of Primary Palmer Hyper Hidrosis

NCT ID: NCT05875285

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-10-01

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.

Conditions

Hyperhidrosis; Iontophore

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Methotreaxate iontophoresis

Thirty patients of both sexes of primary palmar hyperhidrosis are selected to participate in this group from EL KASR EL- AINI

Group Type: EXPERIMENTAL

Iontophoresis with methotrexate

Intervention Type: OTHER

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.

Coal tar ointment

Thirty patients of both sexes of primary palmar hyperhidrosis are selected to participate in this group from EL KASR EL- AINI

Group Type: EXPERIMENTAL

Iontophoresis with coal tar ointement

Intervention Type: OTHER

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.

Interventions

Iontophoresis with methotrexate

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

Iontophoresis with coal tar ointement

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Nayera Radwan Fathy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nayera Radwan

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Outpatient clinic faculty of physical therapy cairo university

Cairo, , Egypt

Countries

Egypt

Central Contacts

Nayera Radwan

Role: CONTACT

nayera.radwa55@gmail.com

+201000206016

Other Identifiers

Nayera_Radwan_2023

Identifier Type: -

Identifier Source: org_study_id