Adding a wheat gliadin biopolymer to superoxide dismutase (SOD) and including the oral compound with phototherapy treatment for vitiligo improved patients’ Vitiligo Extent Scores (VES) by nearly20%, according to findings from a prospective randomized placebo-controlled study published in the Journal of The European Academy of Dermatology and Venereology.
Investigators included patients 18 years and older with widespread nonsegmental vitiligo affecting at least 5% of their body surface area and randomly assigned them 1:1 to receive 1,000mg of oral Glisodin, a gliadin-protected SOD (GP-SOD), for 12 weeks followed by 500 mg of oral Glisodin for 12 weeks, or an oral placebo. Both cohorts received NB-UVB twice weekly for the full 24 weeks. Physicians evaluated standardized photographs taken at weeks 12 and 24 using VES, the gold-standard for assessing vitiligo extent. Quality of life was assessed with the Dermatology Life Quality Index (DLQI) and side effects were graded using the Common Terminology Criteria for Adverse Events (CTCAE).
There were 50 patients included in the final analysis, with a mean age of 48.4 years in the GP-SOD group and 50.9 years in the placebo group. At week 12, the adjusted mean percent improvement in VES was 9.74% (SE 2.36, P =.0002) in the GP-SOD group vs 4.81% (SE 2.40, P =.0515) in the placebo group compared with baseline. At week 24, the adjusted mean improvement in VES was 19.85% (SE 4.63, P <.0001) in the GP-SOD group vs 8.83% (SE 4.72, P =.0676) in the placebo group compared with baseline. The repigmentation rate was higher in the GP-SOD group but not significantly different from the placebo group (P =.089).
The adjusted mean improvement in the DLQI score at week 12 was 1.51 (SE 0.71, P =.0386) in the GP-SOD group vs 0.84 (SE 0.79, P =0.2935) in the placebo group compared with baseline. At week 24, the mean improvement in DLQI was 2.47 (SE 0.56, P <.0001) in the GP-SOD group vs 1.85 (SE 0.62, P =.004) in the placebo group compared with baseline.
There were 18 adverse events reported by the GP-SOD group and 16 in the placebo group, all of which were mild and transient. Tolerance was excellent overall in both groups.
The study was limited by its patient population as most (92%) had failed previous treatments, had a mean disease duration of more than 20 years, and therefore had very stable disease. In addition, twice-weekly NB-UVB sessions compared with 3 times weekly sessions in previous studies may have contributed to the low response rates in the placebo group.
Investigators noted that their study clearly demonstrates “the usefulness of antioxidants in treating vitiligo,” a topic that is lacking in supportive data. SOD, a key antioxidant enzyme, is normally deactivated in the gastrointestinal tract unless it is combined with a protective agent.
Fontas E, Montaudié H, Passeron T. Oral gliadin-protected superoxide dismutase in addition to phototherapy for treating non-segmental vitiligo: A 24-week prospective randomized placebo-controlled study. J Eur Acad Dermatol Venereol. Published online April 30, 2021. doi:10.1111/jdv.17331