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

NCT05875285 | Unknown DMC

• 1 other identifier: Nayera_Radwan_2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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?

Conditions

Hyperhidrosis; Iontophore

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Methotreaxate iontophoresis

EXPERIMENTAL

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

Other: Iontophoresis with methotrexate

Coal tar ointment

EXPERIMENTAL

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

Other: Iontophoresis with coal tar ointement

Interventions

Iontophoresis with methotrexate 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.

Methotreaxate iontophoresis

Iontophoresis with coal tar ointement 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.

Coal tar ointment

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Outpatient clinic faculty of physical therapy cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Hyperhidrosis

Interventions

Iontophoresis; Methotrexate

Condition Hierarchy (Ancestors)

Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Electrophoresis; Electrochemical Techniques; Investigative Techniques; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nayera Radwan

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nayera Radwan

CONTACT

+201000206016; nayera.radwa55@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: June 1, 2023
• Primary Completion: August 20, 2023
• Study Completion: October 1, 2023
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)