Fractional CO2 Laser-assisted Cutaneous Delivery of Methotrexate Versus

Status Not yet recruiting

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Vitiligo

Clinical Trial Details

NCT number	NCT05008887
Study type	Interventional
Source	Assiut University
Contact	Aya M Sayed, Assistant lecturer
Phone	+201024755580
Email	aya_mohamed@med.aun.edu.eg
Status	Not yet recruiting
Phase	Phase 4
Start date	September 2022
Completion date	April 2023

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms