VitiligoPhase 4NCT07352293
The Value of Methotrexate in NCES for Stable Vitiligo
A Phase 4 study testing Non cultured epidermal suspension in people with Vitiligo, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitiligo
- What is being tested?
- Non cultured epidermal suspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2026to 21 Sep 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Dermatology Outpatient Clinic, Kasr al Ainy Teaching Hospital, Cairo University
Cairo
About this study
Official title: The Value of Using Methotrexate Therapy Along With Non Cultured Epidermal Cell Suspension (NCES) in Stable Resistant Vitiligo: An Interventional Prospective Randomized Controlled Trial.
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.
Read the detailed description
Depending on the type, extent, and duration of vitiligo, conventional medical therapies such as topical and systemic corticosteroids, topical immunomodulators, and phototherapy are not always successful, and repigmentation is often incomplete. Acral vitiligo as well as vitiligo over friction sites as elbows and knees are resistant to treatment including surgical procedures. Relatively less melanocyte density as well as higher chances of koebnerization over these friction and injury prone anatomical sites were among the suggestions for poor response to treatment. It was also found that melanocyte growth and migration in acral vitiligo is hindered by several factors such as decreased MMP9, MMP2, c-kit and MHCII expression, together with higher expression of antimelanogenic factors as tenascin and DKK1. Non-cultured epidermal cellular suspension (NCES) is a cellular grafting technique, whose major advantage is permitting treatment of affected skin surface area up to 10 times larger than the donor area without culturing. Methotrexate is an antifolate drug, that decreases the number of T cells. Studies showed that methotrexate has a positive effect on the stabilization of vitiligo. Combined treatment with phototherapy allows better and faster repigmentation than phototherapy alone. Systemic drugs have been previously used perioperatively in vitiligo surgery. Oral betamethasone has been previously used in the peri surgical period and was reported to increase the chances of complete repigmentation in large vitiliginous lesions as activity at the cellular level is still plausible in spite of clinical stability. The aim of this study is to assess whether adding methotrexate therapy to NCES in the peri surgical period would improve repigmentation in acral vitiligo and other resistant sites.
- Inclusion criteria:
- 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
- Lack of topical treatment for at least 1 month prior to surgery and systemic treatment for at least 3 months prior to surgery.
- Exclusion criteria:
- Non acral NSV responsive to conventional treatment modalities
- 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.
- Methodology in details:
- forty lesions in patients with stable vitiligo will be recruited (20 size and region matched lesions per group). An informed written consent will be obtained from patients.
- Patients will be randomized using a computer generated list to one of the two groups which are age and sex matched:
Group A will undergo None cultured epidermal suspension (NCES) without methotrexate.
Group B will receive methotrexate 15 mg/week for 3 months prior to NCES and for 3 months afterwards.
Clinical assessment:
Baseline assessment will include assessing any pigmentation within the patch to be transplanted using the VESTA score and its surface area using point counting technique.
Standardized photographs will be taken at initial assessment, and by the end of the study period after 3 months.
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. It will be covered with a dry collagen sheet followed by sterile surgical pad and tegaderm.
The area will be immobilized after bandaging and the patient will be advised to restrict movement at the operated site.
Patients will start a 1-week course of antibiotics. Dressings will be removed after 1 week, and patients will start topical PUVA hand and feet, 3 times per week for 3 months.
Patients will be followed up monthly for 3 months following the first visit at 1 week.
Both qualitative and quantitative assessment will be done after 3 months of PUVA Hand and feet. Qualitatively, blinded physician assessment of repigmentation as well as color match will be done based on baseline photographs. Quantitatively, point counting method as well as VESTA score will be used as well to assess the surface area of the residual depigmented area and degree of repigmentation respectively.
- Conditions
- Vitiligo
- Being tested
- Non cultured epidermal suspension
- Keywords
- Methotrexate, NCES, acral vitiligo
- Medical subject headings
- Vitiligo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non cultured epidermal suspensionProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| NCES | Active comparator | Not described Receives: Procedure: Non cultured epidermal suspension |
| NCES+Methotexate | Experimental | Not described Receives: Procedure: Non cultured epidermal suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start3 Mar 2026
- Primary completion10 Sep 2026
- Study completion21 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for VitiligoStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nanis Aleem Abdul Moneim Ragab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352293
- Sponsor's protocol ID
- MTXNCES
- Status last verified
- Jun 2026
- First submitted
- 11 Jan 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I will share the deidentified data sheet of the results of the trial
Publications
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.
PubMed 36409563Alghamdi 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.
PubMed 24227963Seneschal 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.
PubMed 37715487Karagaiah 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.
PubMed 31958256Silpa-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.
PubMed 28502377Esmat 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.
PubMed 35373693Abdel 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.
PubMed 37228170Huggins 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.
PubMed 21864935Esmat 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.
PubMed 21851425Falabella R. Surgical approaches for stable vitiligo. Dermatol Surg. 2005 Oct;31(10):1277-84. doi: 10.1111/j.1524-4725.2005.31203.
PubMed 16188179Mulekar 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.
PubMed 16681662
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Using Methotrexate Therapy Along With Non Cultured Epidermal Cell Suspension (NCES) in Stable Resistant Vitiligo: An Interventional Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07352293
- Acronym / sponsor ID
- MTXNCES
- Conditions
- Vitiligo
- Keywords
- Methotrexate, NCES, acral vitiligo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Mar 2026 (actual)
- Primary completion
- 10 Sep 2026 (actual)
- Study completion
- 21 Sep 2026 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Depending on the type, extent, and duration of vitiligo, conventional medical therapies such as topical and systemic corticosteroids, topical immunomodulators, and phototherapy are not always successful, and repigmentation is often incomplete. Acral vitiligo as well as vitiligo over friction sites as elbows and knees are resistant to treatment including surgical procedures. Relatively less melanocyte density as well as higher chances of koebnerization over these friction and injury prone anatomical sites were among the suggestions for poor response to treatment. It was also found that melanocyte growth and migration in acral vitiligo is hindered by several factors such as decreased MMP9, MMP2, c-kit and MHCII expression, together with higher expression of antimelanogenic factors as tenascin and DKK1. Non-cultured epidermal cellular suspension (NCES) is a cellular grafting technique, whose major advantage is permitting treatment of affected skin surface area up to 10 times larger than the donor area without culturing. Methotrexate is an antifolate drug, that decreases the number of T cells. Studies showed that methotrexate has a positive effect on the stabilization of vitiligo. Combined treatment with phototherapy allows better and faster repigmentation than phototherapy alone. Systemic drugs have been previously used perioperatively in vitiligo surgery. Oral betamethasone has been previously used in the peri surgical period and was reported to increase the chances of complete repigmentation in large vitiliginous lesions as activity at the cellular level is still plausible in spite of clinical stability. The aim of this study is to assess whether adding methotrexate therapy to NCES in the peri surgical period would improve repigmentation in acral vitiligo and other resistant sites.
- Inclusion criteria:
- 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
- Lack of topical treatment for at least 1 month prior to surgery and systemic treatment for at least 3 months prior to surgery.
- Exclusion criteria:
- Non acral NSV responsive to conventional treatment modalities
- 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.
- Methodology in details:
- forty lesions in patients with stable vitiligo will be recruited (20 size and region matched lesions per group). An informed written consent will be obtained from patients.
- Patients will be randomized using a computer generated list to one of the two groups which are age and sex matched:
Group A will undergo None cultured epidermal suspension (NCES) without methotrexate.
Group B will receive methotrexate 15 mg/week for 3 months prior to NCES and for 3 months afterwards.
Clinical assessment:
Baseline assessment will include assessing any pigmentation within the patch to be transplanted using the VESTA score and its surface area using point counting technique.
Standardized photographs will be taken at initial assessment, and by the end of the study period after 3 months.
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. It will be covered with a dry collagen sheet followed by sterile surgical pad and tegaderm.
The area will be immobilized after bandaging and the patient will be advised to restrict movement at the operated site.
Patients will start a 1-week course of antibiotics. Dressings will be removed after 1 week, and patients will start topical PUVA hand and feet, 3 times per week for 3 months.
Patients will be followed up monthly for 3 months following the first visit at 1 week.
Both qualitative and quantitative assessment will be done after 3 months of PUVA Hand and feet. Qualitatively, blinded physician assessment of repigmentation as well as color match will be done based on baseline photographs. Quantitatively, point counting method as well as VESTA score will be used as well to assess the surface area of the residual depigmented area and degree of repigmentation respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NCES | Active comparator | Procedure: Non cultured epidermal suspension |
| NCES+Methotexate | Experimental | Procedure: Non cultured epidermal suspension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non cultured epidermal suspensionUnder 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. | Procedure or surgery | NCES, NCES+Methotexate |
Primary outcome
Percent change in surface area by point counting method after NCES alone versus NCES combined with MTX
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 36409563Tavitova 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.
- Background: PubMed 24227963Alghamdi 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.
- Background: PubMed 37715487Seneschal 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.
- Background: PubMed 31958256Karagaiah 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.
- Background: PubMed 28502377Silpa-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.
- Background: PubMed 35373693Esmat 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.
- Background: PubMed 37228170Abdel 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.
- Background: PubMed 21864935Huggins 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.
- Background: PubMed 21851425Esmat 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.
- Background: PubMed 16188179Falabella R. Surgical approaches for stable vitiligo. Dermatol Surg. 2005 Oct;31(10):1277-84. doi: 10.1111/j.1524-4725.2005.31203.
- Background: PubMed 16681662Mulekar 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.
- Individual participant dataSharing planned: Yes. I will share the deidentified data sheet of the results of the trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non cultured epidermal suspension in people with Vitiligo, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in surface area by point counting method after NCES alone versus NCES combined with MTX (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07352293, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.