Efficacy of Transplantation of Combination of Noncultured Dermal and Epidermal Cell Suspension vs Epidermal Cell Suspension Alone in Vitiligo: A Randomized Clinical Trial

Abstract

Importance: Surgical interventions, notably noncultured epidermal suspension (NCES), are the next line of treatment in patients with vitiligo who fail to respond to medical therapy. Noncultured epidermal suspension is usually performed in patients with vitiligo with duration of clinical stability (DS) of 12 months or longer because DS is a vital parameter in determining outcome of NCES. In this pilot study, we planned to assess the efficacy of a novel combination of noncultured epidermal cell suspension and noncultured dermal cell suspension (NCES and NDCS) in patients with vitiligo with shorter DS (3-6 months).

Objective: To compare the efficacy of transplantation of NCES and NDCS vs NCES alone in patients with vitiligo with DS of 3 to 6 months.

Design, setting, and participants: A single-center randomized clinical trial including 40 patients with focal, segmental, or generalized vitiligo with DS of 3 to 6 months or more than 12 months was carried out. Based on DS, 2 groups including 20 patients each were recruited (DS in group 1, 3 to 6 months; DS in group 2, more than 12 months). Each group was further randomized into 2 subgroups, A and B.

Intervention: Patients in subgroups 1A and 2A underwent NCES alone, whereas patients in subgroups 1B and 2B underwent NCES and NDCS.

Main outcomes and measures: Extent of repigmentation, color match, and pattern of repigmentation at 24 weeks.

Results: Of the 40 study participants, mean (SD) age was 24.9 (4.0) years and 24 (60%) were women; in group 1 with DS for 3 to 6 months, more than 75% repigmentation at 24 weeks was observed in all 10 patients in subgroup 1B (NCES and NDCS) compared with 3 of 10 patients in subgroup 1A (NCES) (100% vs 30%, P = .003). In group 2 (DS > 12 months), the same was observed in 6 of 10 patients in subgroup 2A and 7 of 10 patients in subgroup 2B (NCES) (60% vs 70%, P > .99). The 2 groups and subgroups did not show any significant differences with respect to color matching and pattern of repigmentation.

Conclusions and relevance: Combination of NCES and NDCS resulted in excellent response in patients with vitiligo with shorter duration of clinical stability compared with NCES alone. This combination may be used early in the course of stable vitiligo without waiting for a period of 12 months or more since last clinical activity.

Trial registration: ClinicalTrials.gov identifier: NCT03013049.

Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1.. Flowchart Depicting Study Protocol With Inclusion and Exclusion of Patients and Allocation of Patients Into Groups and Subgroups

NCES indicates noncultured epidermal suspension; NDCS, noncultured dermal cell suspension.

Figure 2.. Comparative Photographs of Study Participants at Presentation and at 24 Weeks’ Follow-up Following the Procedures in Subgroups 1A and 1B

Figure 3.. Comparative Photographs of Study Participants at Presentation and at 24 Weeks’ Follow-up Following the Procedures in Subgroups 2A and 2B