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Not yet recruitingNCT05875285Updated May 25, 2023

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

An interventional study of Iontophoresis with methotrexate and Iontophoresis with coal tar ointement in Hyperhidrosis and Iontophore, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 15 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-25.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2023, 3 years 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
15 Years to 35 Years
Sex
All
01

Study 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?

Read the 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.

02

Conditions studied

  • Hyperhidrosis
  • Iontophore

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03

In context

Hyperhidrosis

111 studies on the registry are indexed under Hyperhidrosis; 10 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 99 interventional studies indexed under Hyperhidrosis.

Browse Hyperhidrosis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Methotreaxate iontophoresis

    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

  • Experimental
    Coal tar ointment

    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

  • OtherIontophoresis 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.

  • OtherIontophoresis 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: at baseline and after 4 weeks of intervention

  2. 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

    Time frame: at baseline and after 4 weeks of intervention

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2023; primary completion for Aug 2023, 2 months later.

Of 20 interventional studies with no phase under Hyperhidrosis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 37. This study's planned 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2023
First posted
May 25, 2023
StartEst.
Jun 1, 2023
Primary completionEst.
Aug 20, 2023
CompletionEst.
Oct 1, 2023
Last update
May 25, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05875285
Lead sponsor
Cairo University
Responsible party
Nayera Radwan Fathy (Principal Investigator, Cairo University) — Principal investigator
First posted
May 25, 2023
Start date
Jun 1, 2023 (estimated)
Primary completion
Aug 20, 2023 (estimated)
Completion
Oct 1, 2023 (estimated)
Last update
May 25, 2023

Study contacts

Nayera Radwan
Contact
nayera.radwa55@gmail.com
+201000206016
Nayera Radwan
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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