The Value of Methotrexate in NCES for Stable Vitiligo

Condition(s) studied

Investigational drug(s) / intervention(s)

Non cultured epidermal suspension: Under aseptic precautions and local anesthesia, a Thiersch graft about one-third the size of the recipient area will be harvested from the donor site (usually upper thigh/ buttocks). The skin graft will be transferred to trypsin-EDTA solution and incubated at 37 °C for 20-30 minutes to separate epidermis from the dermis and then washed with PBS. The tissue will be teased gently with sterile forceps to release epidermal cells from the trypsin digested graft. The white dermis will be removed, and the suspension will be centrifuged at 1000g for 5-10 minutes and the supernatant will be discarded. Under strict asepsis, the recipient vitiliginous areas will be anesthetized followed by fractional laser CO2 resurfacing, using dot mode off resurfacing at a power of 18-20 W, dwell time 1,500-2000 milliseconds (DEKA, Florence, Italy). One to three passes will be performed until the epidermis is removed uniformly. Then, the NCES will be applied and uniformly spread.

Study summary

The goal of this clinical trial is to learn if adding a six months course of Methotrexate would improve the results of non cultured epidermal suspension (NCES) in adult patients with acral and resistant vitiligo lesions over the elbows and knees. researchers will compare results of NCES in two groups one group will receive Methotrexate for 3 months prior to the procedure and 3 months after the procedure, while the other group will not receive the drug. Patients will receive PUVA hand \& feet 3 times/week for 3 months after NCES during this period they will be followed up monthly to evaluate repigmentation.

Eligibility

Primary outcome measure(s)

• Percent change in surface area by point counting method after NCES alone versus NCES combined with MTX — 3 months
  A decrease in the surface area (number of points) of depigmented area indicates successful regimentation
• Percent change in surface area by VESTA score after NCES alone versus NCES combined with MTX — 3 months
  VESTA score ranges between 0-100% (0 % is complete depigmentation and 100% is fully pigmented) an increase in VESTA score indicates successful regimentation

Trial sites (1)

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