Vitiligo - Evaluation of Methotrexate Iontophoresis and Topical Methotrexate Gel as Localized Treatment ApproacheNCT07208890
Methotrexate Iontophoresis Versus Methotrexate 1% Gel on Depigmentation in Vitiligo Patients
A study testing Methotrexate Iontophoresis/a low-intensity electric current in people with Vitiligo - Evaluation of Methotrexate Iontophoresis and Topical Methotrexate Gel as Localized Treatment Approache, run by Pharos University in Alexandria.
Trial summary
Vitiligo is a common autoimmune depigmenting disorder characterized by selective destruction of melanocytes. Methotrexate (MTX) has shown potential in stabilizing disease activity and promoting repigmentation; however, systemic administration may cause hepatotoxicity. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitiligo - Evaluation of Methotrexate Iontophoresis and Topical Methotrexate Gel as Localized Treatment Approache
- What is being tested?
- Methotrexate Iontophoresis/a low-intensity electric current
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2025to 10 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria:Clinically diagnosed vitiligo confirmed by a dermatologist.
Stable vitiligo for at least 6 months (no new lesions or progression).
Age between 18 and 60 years.
Both male and female patients.
Presence of localized or segmental vitiligo suitable for topical treatment.
Willingness to avoid other vitiligo treatments (e.g., phototherapy, corticosteroids) during the study period.
Able and willing to provide written informed consent and comply with study procedures -
Exclusion Criteria:History of systemic or topical methotrexate use within the past 3 months.
Unstable or rapidly progressive vitiligo during the last 6 months.
Presence of other autoimmune or dermatologic disorders that could interfere with study evaluation (e.g., psoriasis, eczema, lupus).
Known hypersensitivity or allergy to methotrexate or any gel/iontophoresis components.
Hepatic, renal, or hematologic impairment (abnormal liver function or renal profile).
Pregnant or breastfeeding women, or those planning pregnancy during the study period.
Use of phototherapy, corticosteroids, or immunosuppressive therapy within the last 3 months.
Metal implants or pacemakers, which may contraindicate iontophoresis
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About this study
Vitiligo is a common autoimmune depigmenting disorder characterized by selective destruction of melanocytes. Methotrexate (MTX) has shown potential in stabilizing disease activity and promoting repigmentation; however, systemic administration may cause hepatotoxicity. This pilot study aims to compare the efficacy and safety of methotrexate iontophoresis versus topical methotrexate 1% gel in patients with vitiligo. Thirty patients will be randomly assigned into two equal groups: Group A will receive methotrexate iontophoresis (5-10 mA, 15 min/session) for 8 weeks, while Group B will apply methotrexate 1% gel twice daily for 8 weeks. Outcomes will be assessed using the Vitiligo Area and Severity Index (VASI) and the Vitiligo Impact Scale-22 (VIS-22), with liver function monitored monthly
Read the detailed description
Vitiligo is an autoimmune depigmenting disorder characterized by melanocyte destruction. Methotrexate (MTX) has shown potential in modulating autoimmune activity and promoting repigmentation, but systemic use carries hepatotoxic risks. This pilot randomized study compares methotrexate iontophoresis and topical methotrexate 1% gel in stable vitiligo patients. Thirty participants will be assigned equally into two groups: the iontophoresis group will receive MTX via low-intensity electric current sessions for 8 weeks, while the control group will apply topical MTX gel twice daily for the same period. Efficacy will be evaluated using the Vitiligo Area and Severity Index (VASI) and quality of life by the Vitiligo Impact Scale-22 (VIS-22). Liver function will be monitored monthly to ensure safety
- Being tested
- Methotrexate Iontophoresis/a low-intensity electric current
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methotrexate Iontophoresis/a low-intensity electric currentDevice
Also called : Application of methotrexate solution via iontophoresis using a low-intensity electric current (5-10 mA) for 15 minutes per session, once weekly for 4 weeks, then biweekly for another 4 weeks
: Application of methotrexate solution via iontophoresis using a low-intensity electric current (5-10 mA) for 15 minutes per session, once weekly for 4 weeks, then biweekly for another 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate Iontophoresis | Experimental | Methotrexate Iontophoresis (Experimental Group)
Type: Experimental
Description: Participants will receive methotrexate iontophoresis using a low-intensity electric current (5-10 mA) for 15 minutes per session over 8 weeks - once weekly for the first 4 weeks and then every two weeks for the next 4 weeks (total 6 sessions).
Device/Intervention: Iontophoresis with methotrexate solution
Goal: To enhance transdermal drug delivery and promote repigmentation with minimal systemic absorption Receives: Device: Methotrexate Iontophoresis/a low-intensity electric current |
| Topical Methotrexate 1% Ge | Active comparator | Type: Active Comparator
Description: Participants will apply methotrexate 1% gel topically to the affected skin areas twice daily for 8 consecutive weeks.
Intervention: Topical methotrexate 1% gel
Goal: To assess the efficacy and safety of topical methotrexate alone compared to iontophoretic delivery Receives: Device: Methotrexate Iontophoresis/a low-intensity electric current |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitiligo Area and Severity Index (VASI
in Vitiligo Area and Severity Index (VASI) from baseline to week 8 to evaluate the degree of repigmentation
Measured: 2 month
Vitiligo Impact Scale-22 (VIS-22)
quality of life measured by the Vitiligo Impact Scale-22 (VIS-22), percentage of repigmentation in target lesions, and the proportion of participants achieving ≥50% repigmentatio
Measured: 2month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start10 Nov 2025 (estimated)
- Primary completion10 Feb 2026 (estimated)
- Study completion10 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitiligo - Evaluation of Methotrexate Iontophoresis and Topical Methotrexate Gel as Localized Treatment ApproacheStudies of the same condition, open and under way.
- 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
- Model description
- This study follows a randomized, parallel-group design involving 30 patients with stable vitiligo. Participants are randomly assigned into two equal groups: one group receives methotrexate iontophoresis (experimental group), and the other applies topical methotrexate 1% gel (control group). Both groups are treated for 8 weeks, and outcomes are compared based on pigmentation improvement (VASI) and quality of life (VIS-22)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharos University in Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ola Mohamed Elsayed Elgohary, Pharos University in Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208890
- Sponsor's protocol ID
- pharos university
- Status last verified
- Sep 2025
- First submitted
- 27 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because this is a small-scale pilot study, and data sharing is not planned at this stage. Summary results may be available upon request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methotrexate Iontophoresis Versus Methotrexate 1% Gel on Depigmentation in Vitiligo Patients
- ClinicalTrials.gov ID
- NCT07208890
- Acronym / sponsor ID
- pharos university
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pharos University in AlexandriaUniversity, hospital or other
- Study start
- 10 Nov 2025 (estimated)
- Primary completion
- 10 Feb 2026 (estimated)
- Study completion
- 10 Mar 2026 (estimated)
- First posted
- 6 Oct 2025 (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.
Vitiligo is a common autoimmune depigmenting disorder characterized by selective destruction of melanocytes. Methotrexate (MTX) has shown potential in stabilizing disease activity and promoting repigmentation; however, systemic administration may cause hepatotoxicity. This pilot study aims to compare the efficacy and safety of methotrexate iontophoresis versus topical methotrexate 1% gel in patients with vitiligo. Thirty patients will be randomly assigned into two equal groups: Group A will receive methotrexate iontophoresis (5-10 mA, 15 min/session) for 8 weeks, while Group B will apply methotrexate 1% gel twice daily for 8 weeks. Outcomes will be assessed using the Vitiligo Area and Severity Index (VASI) and the Vitiligo Impact Scale-22 (VIS-22), with liver function monitored monthly
Detailed description
Vitiligo is an autoimmune depigmenting disorder characterized by melanocyte destruction. Methotrexate (MTX) has shown potential in modulating autoimmune activity and promoting repigmentation, but systemic use carries hepatotoxic risks. This pilot randomized study compares methotrexate iontophoresis and topical methotrexate 1% gel in stable vitiligo patients. Thirty participants will be assigned equally into two groups: the iontophoresis group will receive MTX via low-intensity electric current sessions for 8 weeks, while the control group will apply topical MTX gel twice daily for the same period. Efficacy will be evaluated using the Vitiligo Area and Severity Index (VASI) and quality of life by the Vitiligo Impact Scale-22 (VIS-22). Liver function will be monitored monthly to ensure safety
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study follows a randomized, parallel-group design involving 30 patients with stable vitiligo. Participants are randomly assigned into two equal groups: one group receives methotrexate iontophoresis (experimental group), and the other applies topical methotrexate 1% gel (control group). Both groups are treated for 8 weeks, and outcomes are compared based on pigmentation improvement (VASI) and quality of life (VIS-22)
| Arm | Type | Receives |
|---|---|---|
| Methotrexate Iontophoresis | Experimental | Device: Methotrexate Iontophoresis/a low-intensity electric currentMethotrexate Iontophoresis (Experimental Group) Type: Experimental Description: Participants will receive methotrexate iontophoresis using a low-intensity electric current (5-10 mA) for 15 minutes per session over 8 weeks - once weekly for the first 4 weeks and then every two weeks for the next 4 weeks (total 6 sessions). Device/Intervention: Iontophoresis with methotrexate solution Goal: To enhance transdermal drug delivery and promote repigmentation with minimal systemic absorption |
| Topical Methotrexate 1% Ge | Active comparator | Device: Methotrexate Iontophoresis/a low-intensity electric currentType: Active Comparator Description: Participants will apply methotrexate 1% gel topically to the affected skin areas twice daily for 8 consecutive weeks. Intervention: Topical methotrexate 1% gel Goal: To assess the efficacy and safety of topical methotrexate alone compared to iontophoretic delivery |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Methotrexate Iontophoresis/a low-intensity electric currentAlso: : Application of methotrexate solution via iontophoresis using a low-intensity electric current (5-10 mA) for 15 minutes per session, once weekly for 4 weeks, then biweekly for another 4 weeks: Application of methotrexate solution via iontophoresis using a low-intensity electric current (5-10 mA) for 15 minutes per session, once weekly for 4 weeks, then biweekly for another 4 weeks | Device | Methotrexate Iontophoresis, Topical Methotrexate 1% Ge |
Primary outcome
Vitiligo Area and Severity Index (VASI
Time frame: 2 month
in Vitiligo Area and Severity Index (VASI) from baseline to week 8 to evaluate the degree of repigmentation
Vitiligo Impact Scale-22 (VIS-22)
Time frame: 2month
quality of life measured by the Vitiligo Impact Scale-22 (VIS-22), percentage of repigmentation in target lesions, and the proportion of participants achieving ≥50% repigmentatio
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because this is a small-scale pilot study, and data sharing is not planned at this stage. Summary results may be available upon request from the principal investigator
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Methotrexate Iontophoresis/a low-intensity electric current in people with Vitiligo - Evaluation of Methotrexate Iontophoresis and Topical Methotrexate Gel as Localized Treatment Approache, run by Pharos University in Alexandria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitiligo Area and Severity Index (VASI (time frame: 2 month). 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 6 Oct 2025.