The first long-term trial of Latisse (bimatoprost ophthalmic solution 0.03 percent, Allergan) shows that daily application of the eyelash enhancer for up to one year is safe and effective for patients with idiopathic and chemotherapy-induced hypotrichosis.
St. Louis - The first long-term trial of Latisse (bimatoprost ophthalmic solution 0.03 percent, Allergan) shows that daily application of the eyelash enhancer for up to one year is safe and effective for patients with idiopathic and chemotherapy-induced hypotrichosis.
For the study, investigators randomized 368 patients with hypotrichosis into five arms for two consecutive six-month treatment periods. Investigators assigned a total of 238 patients with idiopathic hypotrichosis as follows: 119 used bimatoprost daily throughout the entire 12-month study; 60 used bimatoprost for six months, then vehicle for six months; 59 used placebo for six months, followed by bimatoprost for six months.
Researchers also randomized 130 post-chemotherapy patients as such: 96 patients used bimatoprost daily for 12 months; and 34 patients used vehicle for six months, then bimatoprost.
In terms of primary efficacy, at week 16, investigators sought at least a one-point improvement over baseline on a four-point Global Eyelash Assessment (GEA) scale. Investigators also looked for a three-point improvement in the psychological impact of hypotrichosis, as measured by an Eyelash Satisfaction Questionnaire (ESQ).
Among idiopathic patients, 40.2 percent on active treatment met these goals, versus 6.8 percent for placebo (P<0.001; Glaser DA, Ahluwalia G, Weng E, Beddingfield FC. Poster 5272. Presented at: American Academy of Dermatology Annual Meeting; March 16-20, 2012; San Diego). The corresponding figures in the post-chemotherapy cohort were 37.5 and 18.2 percent (P=0.041), respectively.
Furthermore, in the idiopathic cohort at months six and 12, composite efficacy (or the percentage of responders as defined above) among treated patients was 46.2 and 50.4 percent, respectively. When one examines the numbers that went into this analysis, "It's interesting that you can see more change in the GEA assessment scale," Dr. Glaser says. "The satisfaction scales (ESQ) were a little lower compared to what the clinicians could see."
Among all patients, the proportion who achieved at least a one-point jump in GEA rose from 80 percent at month six to 90 percent at month 12, while approximately 47 percent and 62 percent, respectively, of patients experienced at least a three-point improvement in ESQ during the same period.
"I was expecting satisfaction rates to be a little higher," Dr. Glaser says. She says she surmises that perhaps the scale didn't ask the questions in exactly the right way. More likely, she says, "These results underscore how important eyelashes are to patients. They have a pretty high expectation; they're expecting good results."
High-profile advertisements and media coverage of the already-approved drug further fed patients' expectations, she says. Additionally, "The ESQ scale may not been as sensitive to satisfaction as we thought. There had to be a three-point change in satisfaction, and that is very stringent on a five-point scale."