title: Long-term safety and efficacy of bimatoprost solution 0·03% application to the eyelid margin for the treatment of idiopathic and chemotherapy-induced eyelash hypotrichosis: a randomized controlled trial.
abstract: BACKGROUND
  Bimatoprost ophthalmic solution 0·03% is approved in several countries for the treatment of eyelash hypotrichosis. Previous trials were limited to 4 months of treatment and primarily idiopathic hypotrichosis.
  
  
  OBJECTIVE
  To evaluate the long-term safety and efficacy of bimatoprost in patients with idiopathic or chemotherapy-induced hypotrichosis.
  
  
  METHODS
  This multicentre, double-masked, randomized, parallel-group study included two 6-month treatment periods [treatment period 1 (TP1) and treatment period 2 (TP2)]. Patients with idiopathic hypotrichosis were randomized to three treatment groups: (i) bimatoprost (TP1 and TP2); (ii) bimatoprost (TP1) and vehicle (TP2); and (iii) vehicle (TP1) and bimatoprost (TP2). Patients with chemotherapy-induced hypotrichosis were randomized to two treatment groups: (i) bimatoprost or vehicle (TP1) and (ii) bimatoprost (TP2). Primary end point was a composite of at least a one-grade improvement in investigator-assessed Global Eyelash Assessment and at least a three-point improvement in patient-reported Eyelash Satisfaction Questionnaire Domain 2 at month 4. Secondary measures included digitally assessed eyelash characteristics.
  
  
  RESULTS
  The primary efficacy end point was met in both populations (idiopathic responder rate was 40·2% for bimatoprost vs. 6·8% for vehicle; postchemotherapy responder rate was 37·5% for bimatoprost vs. 18·2% for vehicle). Efficacy by month 6 was maintained (idiopathic) or enhanced (postchemotherapy) at 12 months. Treatment effects were maintained for approximately 2 months but markedly diminished 4-6 months following treatment cessation in patients with idiopathic hypotrichosis. No drug-related serious adverse events were reported.
  
  
  CONCLUSIONS
  Daily treatment with bimatoprost ophthalmic solution 0·03% for 1 year was effective and well tolerated in patients with idiopathic and chemotherapy-induced hypotrichosis.
authors.affiliation: Department of Dermatology, Saint Louis University, St Louis, MO, U.S.A.
authors.forename: D A
authors.initials: DA
authors.lastname: Glaser
authors.affiliation: NIHR Wellcome Trust Clinical Research Facility, Southampton General Hospital, University of Southampton, Southampton, U.K.
authors.forename: P
authors.initials: P
authors.lastname: Hossain
authors.affiliation: Department of Dermatology, Nottingham University Hospitals, Nottingham, U.K.
authors.forename: W
authors.initials: W
authors.lastname: Perkins
authors.affiliation: The Dermatology Centre, Salford Royal NHS Foundation Trust, Salford, U.K.|University of Manchester, Manchester, U.K.
authors.forename: T
authors.initials: T
authors.lastname: Griffiths
authors.affiliation: Allergan, Inc., Irvine, CA, U.S.A.
authors.forename: G
authors.initials: G
authors.lastname: Ahluwalia
authors.affiliation: Allergan, Inc., Irvine, CA, U.S.A.
authors.forename: E
authors.initials: E
authors.lastname: Weng
authors.affiliation: Department of Medicine, Division of Dermatology, David Geffen School of Medicine, University of California, Los Angeles, CA, U.S.A.|Kythera Biopharmaceuticals, Inc., Westlake Village, CA, U.S.A.
authors.forename: F C
authors.initials: FC
authors.lastname: Beddingfield
mesh_terms: D060433:Administration, Ophthalmic; D000069580:Bimatoprost / Q000008:administration & dosage* / Q000009:adverse effects; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005140:Eyelashes / Q000473:pathology*; D005141:Eyelid Diseases / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D007039:Hypotrichosis / Q000139:chemically induced / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D003879:Dermatologic Agents; D009883:Ophthalmic Solutions; D000069580:Bimatoprost