Study of Bimatoprost Gel on Eyelash Growth
The Role of Bimatoprost Eyelash Gel in Chemotherapy-induced Madarosis: an Analysis of Efficacy and Safety
2 other identifiers
interventional
20
1 country
1
Brief Summary
A internally controlled, single-blinded, randomized controlled trial to investigate the use of Bimatoprost eyelash gel on eyelash growth and appearance in breast cancer patients who suffer from madarosis (loss of eyelashes) due to the side effects of chemotherapy. IND and IRB approval have been obtained.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 10, 2010
CompletedFirst Posted
Study publicly available on registry
September 13, 2010
CompletedJuly 16, 2014
September 1, 2010
7 months
September 10, 2010
July 14, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
eyelash length
eyelash ruler used to measure eyelash length
6 months
Secondary Outcomes (4)
eyelash pigment
6 mos
eyelash thickness
6 mos
eyelash amount
6 mos
eyelash side effects
6 mos
Study Arms (2)
Bimatoprost treated eyelid
EXPERIMENTALone eyelid of the patient was randomized to the treatment arm and given the gel to use
control arm - no gel
NO INTERVENTIONthe other fellow eyelid of the patient did not receive any treatment until month 4 and the patient crossed over to treating both eyelids
Interventions
Bimatoprost 0.03% solution was compounded into a gel - patients used on eyelash margin once daily placing gel with a fingertip or Q-tip for 6 months
Eligibility Criteria
You may qualify if:
- YO females
- madarosis or hypotrichosis (loss of eyelashes) due to chemotherapy used to treat breast cancer
- only breast cancer patients
You may not qualify if:
- inability to follow up, apply gel
- active eye/eyelid infection or inflammatory process
- cancer not related to breast cancer, healthy patients
- males
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (1)
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related Publications (1)
Tosti A, Pazzaglia M, Voudouris S, Tosti G. Hypertrichosis of the eyelashes caused by bimatoprost. J Am Acad Dermatol. 2004 Nov;51(5 Suppl):S149-50. doi: 10.1016/j.jaad.2004.05.002.
PMID: 15577756RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2010
First Posted
September 13, 2010
Study Start
February 1, 2007
Primary Completion
September 1, 2007
Study Completion
December 1, 2008
Last Updated
July 16, 2014
Record last verified: 2010-09