A randomized, open label, comparative, five-arm, controlled study evaluating the benefit and tolerability of oral superoxide dismutase combined with gliadin as add-on neutraceutical therapy with standard therapy in Indian patients with melasma

Maya Vedamurthy; Philippe Humbert

doi:10.18203/issn.2455-4529.IntJResDermatol20184453

Authors

Maya Vedamurthy RSV Skin and Laser Centre, Chennai, Tamil Nadu, India
Philippe Humbert Department of Dermatology, University Hospital, Head of Laboratory of Cutaneous Engineering and Biology, University Hospital, France

DOI:

https://doi.org/10.18203/issn.2455-4529.IntJResDermatol20184453

Keywords:

Melasma, Superoxide dismutase, MASI, Quality of life, Hyper-pigmentation

Abstract

Background: Melasma management is often difficult and unsatisfactory, and there is need to explore newer modalities for melasma treatment. Disruption in antioxidant balance occurs in melasma. Superoxide dismutase (SOD) is a cellular antioxidant and restores this balance. Our hypothesis is that the oral SOD-Gliadin can replenish the SOD stores in body and quench the ‘reactive oxygen species’-induced damage in melasma.

Methods: A randomized, open label, single centre, comparative, five arm study was conducted in 90 patients with facial mixed melasma, for 12 weeks to evaluate the efficacy, safety and tolerability of two regimens (BD & OD) of oral SOD as add-on treatment with triple combination cream in melasma patients compared with two regimens (BD & OD) of beta-carotene (BC) and placebo. Primary outcome measure was improvement in Melasma Area and Severity Index (MASI) score, and secondary outcome measures were quality of life score, patient satisfaction score, global assessment by investigator and patients. Pair-wise comparisons were performed on adjusted mean using SAS v9.1.3.

Results: There was significant reduction in MASI score with add-on treatment with SOD BD (67.97%) as compared to BC BD (43.04%), BC OD (33.68%) and placebo (22.60%). There was significant reduction in MASI score with SOD OD (51.93%) as compared to placebo (22.60%). The subjective assessments reported by patient and evaluator also ranked SOD BD as a superior regimen.

Conclusions: By inhibiting oxidative stress, nutraceutical SOD-Gliadin Combination offers significantly better efficacy and higher treatment satisfaction as add-on treatment compared to beta-carotene in Indian patients.

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References

Newcomer VD, Lindberg MC, Sternberg TH. A melanosis of the face ("chloasma"). Arch Dermatol. 1961;83:284-99.

Achar A, Rathi SK. Melasma: a clinico-epidemiological study of 312 cases. Indian J Dermatol. 2011;56:380-2.

Pasricha JS, Khaitan BK, Dash S. Pigmentary disorders in India. DermatolClin. 2007;25: 343-52.

Tamega Ade A, Miot LD, Bonfietti C, Gige TC, Marques ME, Miot HA. Clinical patterns and epidemiological characteristics of facial melasma in Brazilian women. J Eur Acad Dermatol Venereol. 2013;27:151–6.

Rivas SH, Pandia AG. Treatment of Melasma with Topical Agents, Peels and Lasers: An Evidence-Based Review. Am J Clin Dermatol. 2013;14(5):359-76.

Shaikh ZI., Mashood AA. Treatment of refractory melasma with combination of topical 5% magnesium ascorbyl phosphate and fluorescent pulsed light in Asian patients. Int J Dermatol, 2011;53:93–9.

Monteiro RC, Kishore BN, Bhat RM, Sukumar D, Martis J, Ganesh HK. A Comparative Study of the Efficacy of 4% Hydroquinone vs 0.75% Kojic Acid Cream in the Treatment of Facial Melasma. Indian J Dermatol. 2013;58(2):157-63.

Jutley GS, Rajaratnam R, Halpern J, Salim A, Emmett C. Systematic review of randomized controlled trials on interventions for melasma: an abridged Cochrane review. J Am Acad Dermatol. 2014;70(2):369–73.

Seçkin HY, Kalkan G, Baş Y, Akbaş A, Önder Y, Özyurt H et al. Oxidative stress status in patients with melasma. Cutan Ocul Toxicol. 2014;33(3):212-7.

Liu CN, Pettersen B, Seitis G, Osgood S, Somps C. GlyT1 inhibitor reduces oscillatory potentials of the electroretinogram in rats. J Cutaneous Ocular Toxicol. 2014;33(3):206-11.

Dourmishev LA, Dourmishev AL. Craniofacial cavernous hemangioma: succesful treatment with methylprednisolone. Acta Dermatoven APA. 2005;14(2):49-52.

Vorauer-Uhl K, Furnschlief E, Wagner A, Ferko B, Katinger H. Topically applied liposome encapsulated superoxide dismutase reduces postburn wound size and edema formation. Eur J Pharm Sci. 2001;14(1):63–7.

Delanian S, Baillet F, Huart J, Lefaix JL, Maulard C, Housset M. Successful treatment of radiation-induced fibrosis using liposomal Cu/Zn superoxide dismutase: clinical trial. Radiother Oncol 1994;32(1):12–20.

Schmitt K, Simoneau G, Lemaire B, Lacan D. A double-blind, randomized placebo controlled clinical study demonstrates Cellulight® activity on cellulite.

Sanclemente G, Garcia JJ, Zuleta JJ, Diehl C, Correa C, Falabella R. A double-blind, randomized trial of 0.05% betamethasone vs. topical catalase/dismutase superoxide in vitiligo. J Eur Acad Dermatol Venereol. 2008;22(11):1359–64.

Kar HK. Efficacy of beta-carotene topical application in melasma - An open clinical trial. Indian J Dermatol Venereol Leprol. 2003;69:92-4.

MG Clemente, S De Virgiliis, JS Kang, R Macatagney, MP Musu, MR Di Pierro, S Drago, M Congia, A Fasano. Early effects of gliadin on enterocyte intracellular signalling involved in intestinal barrier function. Gut. 2003;52:218-23.

Muth CM, Glenz Y, Klaus M, Radermacher P, Speit G, Leverve X. Influence of an orally effective SOD on hyperbaric oxygen related cell-damage. Free Radical Res. 2004;38(9):927-32.

Mac-Mary M, Sainthillier J, Creidi P, Series JP, Vix F, Humbert Ph. Could a photobiological test be a suitable method to assess the anti-oxidant effect of a nutritional supplement (Glisodin®)? Eur J Dermatol. 2007;17(3):254-5.

Taylor A, Pawaskar M, Taylor SL, Balkrishnan R, Feldman SR. Prevalence of pigmentary disorders and their impact on quality of life: a perspective cohort study. J Cosmet Dermatol. 2008;7:164–8.

Grimes PE. Management of hyperpigmentation in darker racial ethnic groups. Semin Cutan Med Surg. 2009;28:77–85.

Guldvog B. Can patient satisfaction improve health among patients with angina pectoris? Int J Qual Health Care. 1999;11:233–40.

Asadi-Lari M, Tamburini M, Gray D. Patients’ needs, satisfaction, and health related quality of life: towards a comprehensive model. Health Qual Life Outcomes. 2004;2:32.

Laverdet C, Pomarede N. Oliveres-Ghouti C. “Glisodin and Exposure to the Sun,” an open study conducted in France on 150 patients by 40 dermatologists. Sponsored by ISOCELL Nutra, France, 2005.