title: Ginkgo biloba for the treatment of vitilgo vulgaris: an open label pilot clinical trial.
abstract: BACKGROUND
  Vitiligo 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.
  
  
  METHODS
  12 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.
  
  
  RESULTS
  After 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.
  
  
  CONCLUSIONS
  The 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.
  
  
  BACKGROUND
  Clinical trials.gov registration number NCT00907062.
authors.affiliation: Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, 130 Dundas St East, Suite 305, Mississauga, ON L5A 3V8, Canada. orest@noumena.ca
authors.forename: Orest
authors.initials: O
authors.lastname: Szczurko
authors.forename: Neil
authors.initials: N
authors.lastname: Shear
authors.forename: Anna
authors.initials: A
authors.lastname: Taddio
authors.forename: Heather
authors.initials: H
authors.lastname: Boon
mesh_terms: D000293:Adolescent; D000328:Adult; D002648:Child; D003879:Dermatologic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D020441:Ginkgo biloba; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D018579:Patient Selection; D008517:Phytotherapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000494:pharmacology / Q000627:therapeutic use*; D012016:Reference Values; D012867:Skin / Q000187:drug effects* / Q000473:pathology; D012880:Skin Pigmentation / Q000187:drug effects*; D016896:Treatment Outcome; D014820:Vitiligo / Q000188:drug therapy* / Q000473:pathology; D055815:Young Adult
chemical_list: D003879:Dermatologic Agents; D010936:Plant Extracts