Clinical trial NCT05008887: Fractional CO2 Laser-assisted Cutaneous Delivery of Methotrexate Versus 5-fluorouracil in Stable Non-segmental Vitiligo
Official title: Efficacy of Fractional CO2 Laser-assisted Cutaneous Delivery of Methotrexate Versus 5-fluorouracil in Stable Non-segmental Vitiligo
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vitiligo
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical evaluation
timeFrame: 6 month (3 months of treatment and 3 months for follow up after last treatment)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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