Clinical trial NCT00907426: Safety and Efficacy Study of Bimatoprost to Treat Hypotrichosis of the Eyelashes After Application to the Eyelid Margin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypotrichosis
Keywords: eyelashes
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2009-05-22
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This one-year study evaluates the long-term safety and effectiveness of bimatoprost solution application to the eyelid margin (where the eyelashes meet the skin) to treat hypotrichosis of the eyelashes (inadequate or not enough eyelashes). There will be two different types of subjects participating in the study 1)those with inadequate eyelashes due to natural causes or 2) those with inadequate eyelashes following a complete course of chemotherapy treatment. There will be two treatment periods of six months each. Subjects will receive either the study medication or vehicle in either of the two treatment periods.


Eligibility criteria: Inclusion Criteria:

* Subjects who have inadequate eyelashes due to natural causes and are not satisfied with their eyelash appearance.
* For the post-chemotherapy population: subjects who have inadequate eyelashes following a complete course of chemotherapy treatment and are not satisfied with their eyelash appearance, are considered free of cancer and are well enough to complete the study.

Exclusion Criteria:

* Subjects with unequal right and left eyelashes, any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants, eyelash extension application.
* Any use of over the counter or prescription use eyelash growth products.
* Subjects requiring eye drop medications for glaucoma.
* Females who are pregnant, nursing or planning a pregnancy during the study or who are of childbearing potential and not using a reliable method of contraception.

Primary outcomes:
measure: Percentage of Treatment Responders at Month 4
timeFrame: Month 4
Secondary outcomes:
measure: Change From Baseline in Upper Eyelash Length at Month 4
timeFrame: Baseline, Month 4
measure: Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4
timeFrame: Baseline, Month 4
measure: Change From Baseline in Upper Eyelash Darkness at Month 4
timeFrame: Baseline, Month 4
Other outcomes:
measure: Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4
timeFrame: Month 4
Locations:
city: San Diego
country: United States
state: California
city: London
country: United Kingdom
state: England
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Wirta D, Baumann L, Bruce S, Ahluwalia G, Weng E, Daniels S. Safety and Efficacy of Bimatoprost for Eyelash Growth in Postchemotherapy Subjects. J Clin Aesthet Dermatol. 2015 Apr;8(4):11-20.
citation: Harii K, Arase S, Tsuboi R, Weng E, Daniels S, VanDenburgh A. Bimatoprost for eyelash growth in Japanese subjects: two multicenter controlled studies. Aesthetic Plast Surg. 2014 Apr;38(2):451-60. doi: 10.1007/s00266-014-0293-7. Epub 2014 Mar 19.