Safety and Efficacy of Bimatoprost 0.03% Solution for the Treatment of Thinning Eyebrows
Condition: Hypotrichosis
MeSH terms: Hypotrichosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study researching the safety and efficacy of Bimatoprost 0.03% soultion versus
      placebo applied to the eyebrow for the treatment of thinning eyebrows. This is a 36 week
      study where Bimatoprost 0.03% solution/placebo will be applied once daily to the subjects
      eyebrow for duration of the study.
    

Detailed description: 
      A parallel, placebo-controlled, single-center, prospective, randomized, double blind, pilot
      trial to demonstrate bimatoprost 0.03% efficacy in eyebrow hypotrichosis in otherwise healthy
      individuals with thinning eyebrows. Bimatoprost 0.03% or placebo will be applied to the
      eyebrow margin once daily for 36 weeks. Adverse events will be assessed, and subjects will
      complete outcomes questionnaires at study visits. Eyebrow growth and darkening will be scored
      by the investigator and photography will be taken at each study visit.

      Eyebrows are generally composed of three types of hairs: fine vellus hairs are the smallest,
      with the second type slightly larger, lightly pigmented hairs. The supercilia are the large
      terminal hairs which are the most visible and are primarily responsible for color and shape
      of the brow. Eyelashes are composed of terminal hairs, and it has been well demonstrated that
      bimatoprost application on these hairs will render them longer, thicker and darker (Allergan
      Protocol 192024-032). It has also been demonstrated that bimatoprost will darken vellus hair,
      making them more visible. It may be that administering bimatoprost to the eyebrows will cause
      the terminal hair to become longer, thicker and darker, and make the vellus and lightly
      pigmented hairs become more noticeable, thus increasing the intensity and fullness of the
      entire brow.

      Multiple studies have been conducted to assess the safety and efficacy of the application of
      bimatoprost solution to the eyelid for growth of natural eyelashes (Yoelin S, et al, 2010).
      In 2 active-controlled phase 3 studies for LUMIGAN®, eyelash growth was reported as an
      adverse event after 3 months of treatment of subjects receiving bimatoprost once daily
      (Allergan Studies 192024-008 and 192024-009). The application of bimatoprost solution to the
      eyelid has proven to be effective in enhancing eyelash growth in women when applied daily for
      12 weeks (Cohen JL, 2010).

      This drug effect has been formally acknowledged in the LUMIGAN® package insert (Appendix 5.2)
      further supporting the bimatoprost's effect on eyelash growth. The package insert indicates
      that LUMIGAN® may gradually change eyelashes with regard to increased length, thickness,
      pigmentation, and number of eyelashes. Since its US approval in 2001, several adverse events
      of "growth of eyelashes" have been reported in conjunction with the use of LUMIGAN®.

      Subjects will be randomized to Track A, active study drug, bimatoprost 0.03% solution, or to
      Track B, placebo. Each track will apply the same dose, 1 drop per eyebrow once daily, to
      determine the safety and efficacy of bimatoprost 0.03% solution versus placebo.
    

Intervention name(s): Track A; Track B
Intervention type(s): Drug; Drug
Intervention description(s): Bimatoprost 0.03% solution applied to eyebrow; Refresh Tears applied to eyebrows
Other intervention name(s): Active study drug; Bimatoprost 0.03% solution; Placebo control group; Refresh Tears
Intervention MeSH terms: Bimatoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Eyebrow; Hypotrichosis; Thinning; Bimatoprost