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Safety and Efficacy Study of Bimatoprost to Treat Hypotrichosis of the Eyelashes After Application to the Eyelid Margin

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ClinicalTrials.gov Identifier: NCT00907426
Recruitment Status : Completed
First Posted : May 22, 2009
Results First Posted : September 19, 2012
Last Update Posted : September 19, 2012
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypotrichosis Drug: Bimatoprost 0.03% solution Drug: Vehicle solution Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 368 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hair Loss
Drug Information available for: Bimatoprost

Arms and Interventions
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Arm Intervention/treatment
Experimental: Bimatoprost 0.03% Followed by Bimatoprost 0.03%
Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
 Drug: Bimatoprost 0.03% solution
Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
Other Name: LATISSE™
Bimatoprost 0.03% Followed by Vehicle
Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.
 Drug: Bimatoprost 0.03% solution
Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
Other Name: LATISSE™

Drug: Vehicle solution
Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
Other Name: LATISSE™
Vehicle Followed by Bimatoprost 0.03%
Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
 Drug: Bimatoprost 0.03% solution
Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
Other Name: LATISSE™

Drug: Vehicle solution
Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
Other Name: LATISSE™


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Treatment Responders at Month 4 [ Time Frame: Month 4 ]
    Percentage of Treatment Responders at Month 4 defined by: a) at least a 1-grade improvement from baseline in the Global Eyelash Assessment (GEA) score, AND b) at least a 3-point improvement from baseline in the total score for Domain 2 of the Eyelash Symptom Questionnaire (ESQ). The GEA 4-point scale assessed eyelash prominence from 1 (minimal) to 4 (very marked). Domain 2 of the ESQ assessed subjective attributes of confidence, attractiveness, and professionalism rated on a 5-point scale from 1 (very much disagree) to 5 (very much agree) for a total score between 3 and 15.


Secondary Outcome Measures :
  1. Change From Baseline in Upper Eyelash Length at Month 4 [ Time Frame: Baseline, Month 4 ]
    Change from Baseline to in upper eyelash length at Month 4, measured in millimeters (mm). Data from both eyes were averaged for each subject for analysis. Changes from baseline represented by positive values indicated longer length, and changes from baseline represented by negative values indicated shorter length.

  2. Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4 [ Time Frame: Baseline, Month 4 ]
    Change from baseline in average progressive upper eyelash thickness at Month 4 was measured within 3 preset areas. Eyelash thickness was assessed across both eyes as an average of the 3 preset areas measured in millimeters squared (mm^2). Changes from baseline at Month 4 represented by positive values indicated increased eyelash thickness, and changes from baseline represented by negative values indicated thinner eyelash thickness.

  3. Change From Baseline in Upper Eyelash Darkness at Month 4 [ Time Frame: Baseline, Month 4 ]
    Change from baseline in upper eyelash darkness at Month 4 was determined by lash intensity within the spline (a narrow area approximately 5 pixels wide that bisects the area of interest). Upper eyelash darkness was measured in both eyes and averaged for analysis. Colors ranged from black=0 to white=255. Lower numbers on this continuum indicated darker colors. A negative number value change from baseline indicated increased eyelash darkening.


Other Outcome Measures:
  1. Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4 [ Time Frame: Month 4 ]
    Percentage of subjects with at least a 1-grade improvement in GEA score at Month 4. The GEA scale is an investigator-graded 4-point scale of overall eyelash prominence where 1=minimal, 2=moderate, 3=marked, and 4=very marked prominence.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907426


Locations
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United States, California
San Diego, California, United States
United Kingdom
London, England, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00907426    
Other Study ID Numbers: 192024-038
First Posted: May 22, 2009    Key Record Dates
Results First Posted: September 19, 2012
Last Update Posted: September 19, 2012
Last Verified: August 2012
Keywords provided by Allergan:
eyelashes
Additional relevant MeSH terms:
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Hypotrichosis
Hair Diseases
Skin Diseases
 Bimatoprost
Pharmaceutical Solutions
Antihypertensive Agents