Fractional CO2 Laser-assisted Cutaneous Delivery of Methotrexate Versus 5-fluorouracil in Stable Non-segmental Vitiligo

May 6, 2022 updated by: Aya Mohamed, Assiut University

Efficacy of Fractional CO2 Laser-assisted Cutaneous Delivery of Methotrexate Versus 5-fluorouracil in Stable Non-segmental Vitiligo

Vitiligo is a common acquired, depigmenting skin disease that affect the patient's psychological state and quality of life.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Vitiligo is a common acquired, depigmenting skin disease that affect the patient's psychological state and quality of life.

Regarding treatment of vitiligo, several modalities are available but none are completely satisfactory. Recently, fractional carbon dioxide (CO2) laser has been introduced as an add-on treatment for vitiligo.

Fractional CO2 laser acts by stimulating the release of cytokines and growth factors that act as mitogens for melanogenesis. Also, microscopic ablative zones produced by it promote the trans-epidermal penetration of topical agents, providing additional benefits for re-pigmentation.

Recently topical methotrexate 1% gel was used in a case report of vitiligo and was applied to a single patch twice daily for 12 weeks with significant improvement in pigmentation without local or systemic side effects during the course of therapy. Thus, it may prove to be an important steroid sparing agent in treatment of vitiligo.

As methotrexate is a large, hydrophilic molecule that does not penetrate intact skin, several drug delivery systems are being developed e.g. nano-vehicle preparations and laser-assisted delivery. One study has evaluated fractional Erbium laser-assisted delivery of topical methotrexate in porcine skin and found that methotrexate distribution and concentration in the mid-dermis was facilitated by ablative fractional laser, suggesting that ablative fractional laser-assisted topical methotrexate-delivery may be an appropriate alternative to systemic methotrexate for some skin disorders.

Ablative fractional laser-assisted delivery of topical 5-fluorouracil has been used in vitiligo in several studies with good results.

Serum interleukin-23 levels were significantly higher in vitiligo patients as compared with controls.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The patients will be enrolled in the study if they have:

  • Non-segmental vitiligo
  • Stable disease (a patient reporting no new lesions, no progression of existing lesions, and absence of Koebner phenomenon during the past 1 year)

Exclusion Criteria:

  1. History of skin cancers, keloid, hypertrophic scars or photosensitivity.
  2. Use of any topical medications, phototherapy, or laser for vitiligo within 1 month prior to enrollment.
  3. Renal, hepatic, hematological or debilitating chronic diseases.
  4. Active inflammation or infection at site of treatment.
  5. Pregnant and lactating females.
  6. Age under 18 years old.
  7. Segmental vitiligo, active or extensive disease.
  8. Unrealistic expectation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fractional CO2 laser and topical methotrexate solution

In all patients, the selected patches of vitiligo will be treated with fractional CO2 laser for 3 sessions at one-month intervals.

In each patient, two patches or their duplicates (if small sized) will be subjected first to fractional CO2 laser treatment at two different energies (half the number of selected patches will be treated with 50 mJ-energy "with the aim to use laser more as a delivery system to drug solution", and the other half will be treated with 100mJ-energy "with the aim to use laser as both therapeutic and delivery system" , followed by topical application of methotrexate solution (2.5% concentration "vial 50mg/2ml" using insulin syringe as 0.1 ml at 1 cm-intervals with a maximum volume of 2 ml per session). Then gentle massage will be done and after about 10 minutes, an occlusive dressing will be applied for 24 hours after the session.

In all patients, the selected patches of vitiligo will be treated with fractional CO2 laser for 3 sessions at one-month intervals.
Drug: Methotrexate
Fractional CO2 laser-assisted cutaneous delivery of methotrexate solution in stable, non-segmental vitiligo
Device: Fractional CO2 laser
Fractional CO2 laser-assisted cutaneous delivery of methotrexate and 5-fluorouracil solution in stable, non-segmental vitiligo
Active Comparator: Fractional CO2 laser and topical 5-fluorouracil solution

In all patients, the selected patches of vitiligo will be treated with fractional CO2 laser for 3 sessions at one-month intervals.

In each patient, two patches or their duplicates (if small sized) will be subjected first to fractional CO2 laser treatment at two different energies (half the number of selected patches will be treated with 50 mJ-energy "with the aim to use laser more as a delivery system to drug solution", and the other half will be treated with 100mJ-energy "with the aim to use laser as both therapeutic and delivery system" , followed by topical application of 5-fluorouracil solution 5% concentration "vial 250mg/5ml" using insulin syringe as 0.1 ml at 1 cm-intervals with a maximum volume of 2 ml per session). Then gentle massage will be done and after about 10 minutes, an occlusive dressing will be applied for 24 hours after the session.

In all patients, the selected patches of vitiligo will be treated with fractional CO2 laser for 3 sessions at one-month intervals.
Device: Fractional CO2 laser
Fractional CO2 laser-assisted cutaneous delivery of methotrexate and 5-fluorouracil solution in stable, non-segmental vitiligo
Drug: 5-fluorouracil
Fractional CO2 laser-assisted cutaneous delivery of 5-fluorouracil solution in stable, non-segmental vitiligo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation
Time Frame: 6 month (3 months of treatment and 3 months for follow up after last treatment)

Photographic evaluation

  • Patients will be evaluated by digital photographs at baseline, before each session and monthly for 3 months after the last session to evaluate the therapeutic response.
  • Two non-treating blinded dermatologists will be asked to record percentage of improvement in the treated patches for each patient after completion of the treatment by comparing before and after digital photographs. The re-pigmentation response will be expressed qualitatively using a quartile grading scale (grade 0 = no improvement; 1, 1-25% = minimal; 2, 26-50% = moderate; 3, 51-75% = good; and 4, >75% = excellent).

Quantitative assessment by the point counting technique:

Quantitative assessment will be done by calculating the area of depigmentation in vitiliginous patches using a simple point counting method at baseline, before each session and at the final evaluation.

The percentage reduction in lesion size will be then calculated.
6 month (3 months of treatment and 3 months for follow up after last treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

August 10, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 6, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTXVITILIGO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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