Eyelash growth in subjects treated with bimatoprost: A multicenter, randomized, double-masked, vehicle-controlled, parallel-group study - 16/04/12
, Steven Fagien, MD b, Scott M. Whitcup, MD c, Fred Ledon, BS c, Christine Somogyi, RN c, Emily Weng, ScD c, Frederick C. Beddingfield, MD, PhD c, d
Reprint requests: Stacy Smith, MD, 2731 Lagoon View Dr, Cardiff, CA 92007.Abstract |
Background |
Bimatoprost 0.03% is associated with increased growth and prominence of eyelashes.
Objective |
We sought to compare the safety and efficacy of once-daily bimatoprost 0.03% versus vehicle in increasing eyelash length, thickness, and darkness after topical administration to upper eyelid margins.
Methods |
In this 5-month study, subjects were randomized to receive once-daily bimatoprost 0.03% (n = 137) or vehicle (n = 141). The primary end point was eyelash prominence assessed by the investigator global eyelash assessment scale. Secondary efficacy measures included eyelash length, thickness, and darkness measured by digital image analysis and patient-reported outcomes. Safety data included adverse event monitoring and ophthalmic examinations.
Results |
A higher percentage of subjects treated with bimatoprost 0.03% (78.1%) versus vehicle (18.4%) demonstrated at least a 1-grade increase in global eyelash assessment score at week 16 (P < .0001). Subjects in the bimatoprost 0.03% group also had statistically significantly greater increases in eyelash length, thickness, and darkness (P < .0001) than those in the vehicle group. For adverse events, only conjunctival hyperemia occurred at a statistically significant higher incidence rate in the bimatoprost 0.03% versus the vehicle group (P = .03).
Limitations |
Short-term duration of the trial was a limitation; black subjects were not enrolled secondary to technical requirements of digital image analysis.
Conclusion |
Bimatoprost 0.03% was found to be effective at enhancing eyelashes in adults with a very good safety profile.
Le texte complet de cet article est disponible en PDF.Key words : bimatoprost, digital image analysis, global eyelash assessment scale, hypotrichosis, prostamide
Abbreviations used : AE, DIA, GEA, IOP, PRO
Plan
| Supported by Allergan, Inc. |
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| Disclosure: Dr Smith serves as a consultant and investigator for Allergan, Inc, and as an investigator for Pfizer Inc. Dr Fagien serves as a consultant and investigator for Allergan, Inc. Dr Whitcup, Dr Beddingfield, Mr Ledon, Ms Somogyi, and Ms Weng are employees of Allergan, Inc. |
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| Clinical Trial Registration Number: NCT00693420 accessible at NCT00693420. First subject enrolled April 30, 2007. Trial registered June 5, 2008. |
Vol 66 - N° 5
P. 801-806 - mai 2012 Retour au numéro
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