HyperhidrosisNCT05875285
Methotrexate Iontophoresis Versus Coal Tar Ointement in the Treatment of Primary Palmer Hyper Hidrosis
A study testing Iontophoresis with methotrexate and Iontophoresis with coal tar ointement in people with Hyperhidrosis and Iontophore, run by Cairo University at 1 site in Egypt.
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? Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperhidrosis, Iontophore
- What is being tested?
- Iontophoresis with methotrexate and Iontophoresis with coal tar ointement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic faculty of physical therapy cairo university
Cairo
About this study
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.
- Conditions
- Hyperhidrosis, Iontophore
- Being tested
- Iontophoresis with methotrexate, Iontophoresis with coal tar ointement
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iontophoresis with methotrexateOther
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 ointementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Methotreaxate iontophoresis | Experimental | Thirty patients of both sexes of primary palmar hyperhidrosis are selected to participate in this group from EL KASR EL- AINI Receives: 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 Receives: Other: Iontophoresis with coal tar ointement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: at baseline and after 4 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion20 Aug 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperhidrosisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nayera Radwan Fathy, Cairo University
- Investigators
- Nayera Radwan, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875285
- Sponsor's protocol ID
- Nayera_Radwan_2023
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methotrexate Iontophoresis Versus Coal Tar Ointement in the Treatment of Primary Palmer Hyper Hidrosis
- ClinicalTrials.gov ID
- NCT05875285
- Acronym / sponsor ID
- Nayera_Radwan_2023
- Conditions
- Hyperhidrosis, Iontophore
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 20 Aug 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotreaxate iontophoresis | Experimental | Other: Iontophoresis with methotrexateThirty patients of both sexes of primary palmar hyperhidrosis are selected to participate in this group from EL KASR EL- AINI |
| Coal tar ointment | Experimental | Other: Iontophoresis with coal tar ointementThirty patients of both sexes of primary palmar hyperhidrosis are selected to participate in this group from EL KASR EL- AINI |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iontophoresis with methotrexateThe 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. | Other | Methotreaxate iontophoresis |
| Iontophoresis with coal tar ointementFor 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. | Other | Coal tar ointment |
Primary outcome
Assessing the change in Sweat output
Time frame: at baseline and after 4 weeks of intervention
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
Time frame: at baseline and after 4 weeks of intervention
By using Hyperhidrosis disease severity scale. It is a (4) points scale that is used to determine the degree of severity of hyperhidrosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nayera Radwan principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iontophoresis with methotrexate and Iontophoresis with coal tar ointement in people with Hyperhidrosis and Iontophore, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nayera Radwan (+201000206016, nayera.radwa55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing the change in Sweat output (time frame: at baseline and after 4 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.