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

NCT05008887 | Unknown Phase 4

• 1 other identifier: MTXVITILIGO
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Vitiligo

Outcome Measures

Primary Outcomes (1)

• Clinical evaluation

  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)

Study Arms (2)

Fractional CO2 laser and topical methotrexate solution

EXPERIMENTAL

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; Device: Fractional CO2 laser

Fractional CO2 laser and topical 5-fluorouracil solution

ACTIVE COMPARATOR

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.

Drug: 5-fluorouracil; Device: Fractional CO2 laser

Interventions

Methotrexate DRUG

Fractional CO2 laser-assisted cutaneous delivery of methotrexate solution in stable, non-segmental vitiligo

Fractional CO2 laser and topical methotrexate solution

5-fluorouracil DRUG

Fractional CO2 laser-assisted cutaneous delivery of 5-fluorouracil solution in stable, non-segmental vitiligo

Fractional CO2 laser and topical 5-fluorouracil solution

Fractional CO2 laser DEVICE

Fractional CO2 laser-assisted cutaneous delivery of methotrexate and 5-fluorouracil solution in stable, non-segmental vitiligo

Fractional CO2 laser and topical 5-fluorouracil solution; Fractional CO2 laser and topical methotrexate solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (11)

• Lai YC, Yew YW, Kennedy C, Schwartz RA. Vitiligo and depression: a systematic review and meta-analysis of observational studies. Br J Dermatol. 2017 Sep;177(3):708-718. doi: 10.1111/bjd.15199. Epub 2017 Jul 23.

  PMID: 27878819 BACKGROUND

• Agarwal K, Podder I, Kassir M, Vojvodic A, Schwartz RA, Wollina U, Valle Y, Lotti T, Rokni GR, Grabbe S, Goldust M. Therapeutic options in vitiligo with special emphasis on immunomodulators: A comprehensive update with review of literature. Dermatol Ther. 2020 Mar;33(2):e13215. doi: 10.1111/dth.13215. Epub 2020 Jan 12.

  PMID: 31891450 BACKGROUND

• Kim HJ, Hong ES, Cho SH, Lee JD, Kim HS. Fractional Carbon Dioxide Laser as an "Add-on" Treatment for Vitiligo: A Meta-analysis with Systematic Review. Acta Derm Venereol. 2018 Feb 7;98(2):180-184. doi: 10.2340/00015555-2836.

  PMID: 29110015 BACKGROUND

• Shin J, Lee JS, Hann SK, Oh SH. Combination treatment by 10 600 nm ablative fractional carbon dioxide laser and narrowband ultraviolet B in refractory nonsegmental vitiligo: a prospective, randomized half-body comparative study. Br J Dermatol. 2012 Mar;166(3):658-61. doi: 10.1111/j.1365-2133.2011.10723.x. Epub 2012 Jan 19.

  PMID: 22050270 BACKGROUND

• Abdelmaksoud A, Dave DD, Lotti T, Vestita M. Topical methotrexate 1% gel for treatment of vitiligo: A case report and review of the literature. Dermatol Ther. 2019 Sep;32(5):e13013. doi: 10.1111/dth.13013. Epub 2019 Jul 16.

  PMID: 31265164 BACKGROUND

• Aickara D, Bashyam AM, Pichardo RO, Feldman SR. Topical methotrexate in dermatology: a review of the literature. J Dermatolog Treat. 2022 Feb;33(1):512-517. doi: 10.1080/09546634.2020.1770170. Epub 2020 May 25.

  PMID: 32412810 BACKGROUND

• Taudorf EH, Lerche CM, Vissing AC, Philipsen PA, Hannibal J, D'Alvise J, Hansen SH, Janfelt C, Paasch U, Anderson RR, Haedersdal M. Topically applied methotrexate is rapidly delivered into skin by fractional laser ablation. Expert Opin Drug Deliv. 2015 Jul;12(7):1059-69. doi: 10.1517/17425247.2015.1031216. Epub 2015 Apr 20.

  PMID: 25893560 BACKGROUND

• Doghaim NN, El-Tatawy RA, Ismail MA, Ali DAM, El Attar YA. Study the effect of erbium:YAG laser plus topical 5-flurouracil in stable vitiligo resistant to NB-UVB phototherapy. J Cosmet Dermatol. 2020 Jan;19(1):122-130. doi: 10.1111/jocd.13134. Epub 2019 Oct 1.

  PMID: 31571367 BACKGROUND

• Anbar TS, Westerhof W, Abdel-Rahman AT, Ewis AA, El-Khayyat MA. Effect of one session of ER:YAG laser ablation plus topical 5Fluorouracil on the outcome of short-term NB-UVB phototherapy in the treatment of non-segmental vitiligo: a left-right comparative study. Photodermatol Photoimmunol Photomed. 2008 Dec;24(6):322-9. doi: 10.1111/j.1600-0781.2008.00385.x.

  PMID: 19000191 BACKGROUND

• Vaccaro M, Cannavo SP, Imbesi S, Cristani M, Barbuzza O, Tigano V, Gangemi S. Increased serum levels of interleukin-23 circulating in patients with non-segmental generalized vitiligo. Int J Dermatol. 2015 Jun;54(6):672-4. doi: 10.1111/ijd.12392. Epub 2014 Nov 27.

  PMID: 25427848 BACKGROUND

• Kadry M, Tawfik A, Abdallah N, Badawi A, Shokeir H. Platelet-rich plasma versus combined fractional carbon dioxide laser with platelet-rich plasma in the treatment of vitiligo: a comparative study. Clin Cosmet Investig Dermatol. 2018 Nov 8;11:551-559. doi: 10.2147/CCID.S178817. eCollection 2018.

  PMID: 30510437 BACKGROUND

MeSH Terms

Conditions

Vitiligo

Interventions

Methotrexate; Fluorouracil

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Aya M Sayed, Assistant lecturer

CONTACT

+201024755580; aya_mohamed@med.aun.edu.eg

Marwa M Abd El Hakeem Mekkawy, Lecturer

CONTACT

+201004899436; marwamekkawy@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 17, 2021
• Study Start: September 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share