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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00907426
First received: May 20, 2009
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Hypotrichosis
Drug: Bimatoprost 0.03% solution
Drug: Vehicle solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Treatment Responders at Month 4 [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
    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:
  • Change From Baseline in Upper Eyelash Length at Month 4 [ Time Frame: Baseline, Month 4 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Average Progressive Upper Eyelash Thickness at Month 4 [ Time Frame: Baseline, Month 4 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Upper Eyelash Darkness at Month 4 [ Time Frame: Baseline, Month 4 ] [ Designated as safety issue: No ]
    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:
  • Percentage of Subjects With at Least a 1-Grade Improvement in Global Eyelash Assessment (GEA) Score at Month 4 [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
    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.


Enrollment: 368
Study Start Date: August 2009
Study Completion Date: May 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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™

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907426

Locations
United States, California
San Diego, California, United States
United Kingdom
London, England, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00907426     History of Changes
Other Study ID Numbers: 192024-038
Study First Received: May 20, 2009
Results First Received: August 21, 2012
Last Updated: August 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Allergan:
eyelashes

Additional relevant MeSH terms:
Hypotrichosis
Hair Diseases
Skin Diseases
Bimatoprost
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 22, 2014