Abstract
BackgroundVitiligo is a common hypopigmentation disorder with significant psychological impact if occurring before adulthood. A pilot clinical trial to determine the feasibility of an RCT was conducted and is reported here.Methods12 participants 12 to 35 years old were recruited to a prospective open-label pilot trial and treated with 60 mg of standardized G. biloba two times per day for 12 weeks. The criteria for feasibility included successful recruitment, 75% or greater retention, effectiveness and lack of serious adverse reactions. Effectiveness was assessed using the Vitiligo Area Scoring Index (VASI) and the Vitiligo European Task Force (VETF), which are validated outcome measures evaluating the area and intensity of depigmentation of vitiligo lesions. Other outcomes included photographs and adverse reactions. Safety was assessed by serum coagulation factors (platelets, PTT, INR) at baseline and week 12.ResultsAfter 2 months of recruitment, the eligible upper age limit was raised from 18 to 35 years of age in order to facilitate recruitment of the required sample size. Eleven participants completed the trial with 85% or greater adherence to the protocol. The total VASI score improved by 0.5 (P = 0.021) from 5.0 to 4.5, range of scale 0 (no depigmentation) to 100 (completely depigmented). The progression of vitiligo stopped in all participants; the total VASI indicated an average repigmentation of vitiligo lesions of 15%. VETF total vitiligo lesion area decreased 0.4% (P = 0.102) from 5.9 to 5.6 from baseline to week 12. VETF staging score improved by 0.7 (P = 0.101) from 6.6 to 5.8, and the VETF spreading score improved by 3.9 (P < 0.001)) from 2.7 to -1.2. There were no statistically significant changes in platelet count, PTT, or INR.ConclusionsThe criteria for feasibility were met after increasing the maximum age limit of the successful recruitment criterion; participant retention, safety and effectiveness criteria were also met. Ingestion of 60 mg of Ginkgo biloba BID was associated with a significant improvement in total VASI vitiligo measures and VETF spread, and a trend towards improvement on VETF measures of vitiligo lesion area and staging. Larger, randomized double-blind clinical studies are warranted and appear feasible.Trial RegistrationClinical trials.gov registration number NCT00907062
Highlights
Vitiligo is a common hypopigmentation disorder with significant psychological impact if occurring before adulthood
Several studies have found that dopamine can induce apoptosis in human melanocytes [13,14]
The neuronal hypothesis is further supported by the findings that there is close contact between melanocytes and nerve endings in depigmented skin, an observation rarely seen in normal skin [12]
Summary
Vitiligo is a common hypopigmentation disorder with significant psychological impact if occurring before adulthood. Third is the “self-destruct hypothesis”, where melanocytes self-destruct due to defects in protective mechanisms responsible for removing toxic melanin precursors [12] This is thought to lead to the accumulation of melanotoxic indole derivatives and free radicals [12]. Fourth is the “biochemical hypothesis” which postulates an overproduction of a tyrosine hydroxylase cofactor, hydrobiopterin, resulting in increased catecholamine synthesis [12] This is thought to result in increased reactive oxygen species that are toxic to melanocytes [12]. This is supported by findings of reduced catalase and higher concentrations of hydrogen peroxide in affected and unaffected skin of vitiligo sufferers [12,15]
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