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NCT05008887 Clinical Trial

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

Vitiligo Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05008887
Other study ID # MTXVITILIGO
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date September 2022
Est. completion date April 2023

Study information
Verified date May 2022
Source Assiut University
Contact Aya M Sayed, Assistant lecturer
Phone +201024755580
Email aya_mohamed@med.aun.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Methotrexate
Fractional CO2 laser-assisted cutaneous delivery of methotrexate solution in stable, non-segmental vitiligo
• 5-fluorouracil
Fractional CO2 laser-assisted cutaneous delivery of 5-fluorouracil 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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

References & Publications (11)

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Outcome
Type Measure Description Time frame Safety issue
Primary 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)
See also
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