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 g...

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Published inJournal of the European Academy of Dermatology and Venereology Vol. 35; no. 8; pp. 1725 - 1729
Main Authors Fontas, E., Montaudié, H., Passeron, T.
Format Journal Article
LanguageEnglish
Published England John Wiley and Sons Inc 01.08.2021
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Summary: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.
Bibliography:Conflicts of interest
Clinicaltrial.gov registration: NCT03941808
The study was supported by Isocell®. The sponsor did not have any role in the design and conduct of the study, in the collection, analysis or interpretation of the data, neither in the preparation, review or approval of the manuscript; and in the decision to submit the manuscript for publication.
None of the authors received any financial compensation, and none report any conflict of interest.
Funding source
The patients in this manuscript have given written informed consent to the publication of their case details.
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ISSN:0926-9959
1468-3083
1468-3083
DOI:10.1111/jdv.17331