Oral gliadin‐protected superoxide dismutase in addition to phototherapy for treating non‐segmental vitiligo: A 24‐week prospective randomized placebo‐controlled study

BACKGROUND: Despite a solid rationale, the usefulness of antioxidants in treating vitiligo has not been clearly demonstrated. Combining superoxide dismutase (SOD) with a wheat gliadin biopolymer protects it during the passage through the gastrointestinal tract. OBJECTIVE: To evaluate the efficacy of gliadin‐protected SOD (GP‐SOD), associated with narrowband ultraviolet B(NB‐UVB), for treating vitiligo. METHODS: We conducted a 24‐week monocentric interventional prospective randomized placebo‐controlled trial in the tertiary center for vitiligo care in the department of Dermatology of Nice University hospital, Nice, France. Subjects with non‐segmental vitiligo affecting more than 5% of the total body surface were included. The subjects received gliadin‐protected SOD (GP‐SOD; 1 g/day for 12 weeks followed by 0.5 g/day for 12 weeks) or placebo in combination with twice‐weekly sessions of NB‐UVB. The primary endpoint was the total repigmentation rate at 24 weeks, compared with baseline, as assessed by investigator‐assessed Vitiligo Extent Score (VES) on standardized pictures. RESULTS: A total of 50 patients were included. After 24 weeks, a greater improvement in VES was observed in the GP‐SOD group (19.85%; SE 4.63, P < 0.0001) compared with the placebo group (8.83%; SE 4.72, P = 0.0676). Tolerance was good in both groups. No related side‐effect was reported. CONCLUSIONS: The use of GP‐SOD appears to be a useful add‐on to phototherapy in the treatment of vitiligo patients.