The Value of Methotrexate in NCES for Stable Vitiligo

NCT07352293 | Active Not Recruiting Phase 4

• 1 other identifier: MTXNCES
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vitiligo

Keywords

Methotrexate; NCES; acral vitiligo

Outcome Measures

Primary Outcomes (2)

• Percent change in surface area by point counting method after NCES alone versus NCES combined with MTX

  A decrease in the surface area (number of points) of depigmented area indicates successful regimentation

  3 months

• Percent change in surface area by VESTA score after NCES alone versus NCES combined with MTX

  VESTA score ranges between 0-100% (0 % is complete depigmentation and 100% is fully pigmented) an increase in VESTA score indicates successful regimentation

  3 months

Study Arms (2)

NCES

ACTIVE COMPARATOR

Procedure: Non cultured epidermal suspension

NCES+Methotexate

EXPERIMENTAL

Procedure: Non cultured epidermal suspension

Interventions

Non cultured epidermal suspension PROCEDURE

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.

NCES; NCES+Methotexate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with non-segmental vitiligo (NSV) with acral or resistant lesions over the elbows and knees, that has not responded to conventional treatment
• Stability for ≥ 1 year
• Age ≥18 years

You may not qualify if:

• Segmental vitiligo
• Active vitiligo; new lesions, expansion of old lesions, confetti like lesions, ill-defined edges or koebnerization in \< 1 year
• Age \< 18 years.
• Pregnant females.
• Patients with hematologic, hepatic, renal disease or chronic infection.
• Topical treatment in the past month and systemic treatment in the past 3 months.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Dermatology Outpatient Clinic, Kasr al Ainy Teaching Hospital, Cairo University

Cairo, Egypt

Location

Related Publications (11)

• Tavitova A, Valle Y, Lomonosov K. Using methotrexate in the treatment of advanced vitiligo. J Cosmet Dermatol. 2023 Mar;22(3):1136-1138. doi: 10.1111/jocd.15524. Epub 2022 Nov 21. No abstract available.

  PMID: 36409563 BACKGROUND

• Alghamdi K, Khurrum H. Methotrexate for the treatment of generalized vitiligo. Saudi Pharm J. 2013 Oct;21(4):423-4. doi: 10.1016/j.jsps.2012.12.003. No abstract available.

  PMID: 24227963 BACKGROUND

• Seneschal J, Speeckaert R, Taieb A, Wolkerstorfer A, Passeron T, Pandya AG, Lim HW, Ezzedine K, Zhou Y, Xiang F, Thng S, Tanemura A, Suzuki T, Rosmarin D, Rodrigues M, Raboobee N, Pliszewski G, Parsad D, Oiso N, Monteiro P, Meurant JM, Maquignon N, Lui H, Le Poole C, Leone G, Lee AY, Lan E, Katayama I, Huggins R, Oh SH, Harris JE, Hamzavi IH, Gupta S, Grimes P, Goh BK, Ghia D, Esmat S, Eleftheriadou V, Bohm M, Benzekri L, Bekkenk M, Bae JM, Alomar A, Abdallah M, Picardo M, van Geel N. Worldwide expert recommendations for the diagnosis and management of vitiligo: Position statement from the international Vitiligo Task Force-Part 2: Specific treatment recommendations. J Eur Acad Dermatol Venereol. 2023 Nov;37(11):2185-2195. doi: 10.1111/jdv.19450. Epub 2023 Sep 15.

  PMID: 37715487 BACKGROUND

• Karagaiah P, Valle Y, Sigova J, Zerbinati N, Vojvodic P, Parsad D, Schwartz RA, Grabbe S, Goldust M, Lotti T. Emerging drugs for the treatment of vitiligo. Expert Opin Emerg Drugs. 2020 Mar;25(1):7-24. doi: 10.1080/14728214.2020.1712358. Epub 2020 Feb 3.

  PMID: 31958256 BACKGROUND

• Silpa-Archa N, Griffith JL, Huggins RH, Henderson MD, Kerr HA, Jacobsen G, Mulekar SV, Lim HW, Hamzavi IH. Long-term follow-up of patients undergoing autologous noncultured melanocyte-keratinocyte transplantation for vitiligo and other leukodermas. J Am Acad Dermatol. 2017 Aug;77(2):318-327. doi: 10.1016/j.jaad.2017.01.056. Epub 2017 May 11.

  PMID: 28502377 BACKGROUND

• Esmat S, Assaf MI, Mohye Eldeen R, Gawdat HI, Saadi DG. Evaluation of needling/microneedling as an adjunct to phototherapy in the treatment of stable acral vitiligo: a comparative clinical and immunohistochemical study. J Dermatolog Treat. 2022 Aug;33(5):2621-2628. doi: 10.1080/09546634.2022.2062279. Epub 2022 Apr 8.

  PMID: 35373693 BACKGROUND

• Abdel Halim DM, Fekry A, Mogawer RM. The value of adding platelet-rich plasma (PRP) to noncultured epidermal cell suspension (NCECS) in surgical treatment of stable resistant vitiligo: A self-controlled randomised double-blinded study. Australas J Dermatol. 2023 Aug;64(3):359-367. doi: 10.1111/ajd.14080. Epub 2023 May 25.

  PMID: 37228170 BACKGROUND

• Huggins RH, Henderson MD, Mulekar SV, Ozog DM, Kerr HA, Jabobsen G, Lim HW, Hamzavi IH. Melanocyte-keratinocyte transplantation procedure in the treatment of vitiligo: the experience of an academic medical center in the United States. J Am Acad Dermatol. 2012 May;66(5):785-93. doi: 10.1016/j.jaad.2011.05.002. Epub 2011 Aug 23.

  PMID: 21864935 BACKGROUND

• Esmat SM, El-Tawdy AM, Hafez GA, Zeid OA, Abdel Halim DM, Saleh MA, Leheta TM, Elmofty M. Acral lesions of vitiligo: why are they resistant to photochemotherapy? J Eur Acad Dermatol Venereol. 2012 Sep;26(9):1097-104. doi: 10.1111/j.1468-3083.2011.04215.x. Epub 2011 Aug 18.

  PMID: 21851425 BACKGROUND

• Falabella R. Surgical approaches for stable vitiligo. Dermatol Surg. 2005 Oct;31(10):1277-84. doi: 10.1111/j.1524-4725.2005.31203.

  PMID: 16188179 BACKGROUND

• Mulekar SV. Stable vitiligo treated by a combination of low-dose oral pulse betamethasone and autologous, noncultured melanocyte-keratinocyte cell transplantation. Dermatol Surg. 2006 Apr;32(4):536-41. doi: 10.1111/j.1524-4725.2006.32109.x.

  PMID: 16681662 BACKGROUND

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of Dermatology Cairo University

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: March 3, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 month after paper publication

Locations

EG (1)