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

Hyperhidrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05875285
• Other study ID #: Nayera_Radwan_2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: May 2023
• Source: Cairo University
• Contact: Nayera Radwan
• Phone: +201000206016
• Email: nayera.radwa55[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 1, 2023
• Est. primary completion date: August 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperhidrosis

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Outpatient clinic faculty of physical therapy cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at baseline and after 4 weeks of intervention
Primary	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	at baseline and after 4 weeks of intervention