NCT05008887

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Vitiligo

Interventions

Type	Name	Description
DRUG	Methotrexate	Fractional CO2 laser-assisted cutaneous delivery of methotrexate solution in stable, non-segmental vitiligo
DRUG	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

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-03-01
• Completion: 2023-04-01
• First posted: 2021-08-17
• Last updated: 2022-05-09