Bimatoprost in the Treatment of Eyelash Hypotrichosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01698554
First received: October 1, 2012
Last updated: January 27, 2015
Last verified: January 2015
  Purpose

This study will evaluate the safety and efficacy of bimatoprost solution formulation A compared with bimatoprost solution 0.03% (LATISSE®) and vehicle in the treatment of eyelash hypotrichosis (inadequate eyelashes).


Condition Intervention Phase
Idiopathic Eyelash Hypotrichosis
Drug: bimatoprost formulation A solution
Drug: bimatoprost solution 0.03 %
Drug: vehicle of bimatoprost formulation A solution
Drug: vehicle of bimatoprost solution 0.03 %
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Participants With at Least a 1-Grade Increase (Improvement) From Baseline in the Investigator's Assessment of Overall Eyelash Prominence (GEA) [ Time Frame: Baseline, Month 4 ] [ Designated as safety issue: No ]
    The investigator evaluated the overall eyelash prominence in both eyes using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked. A 1-grade improvement in the GEA score from Baseline indicated improvement.


Secondary Outcome Measures:
  • Change From Baseline in Upper Eyelash Length as Measured Using Digital Image Analysis (DIA) [ Time Frame: Baseline, Month 4 ] [ Designated as safety issue: No ]
    Photographs were taken of the eyelashes and assessed using DIA. Length was measured in millimeters (mm). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated longer length (improvement)

  • Change From Baseline in Upper Eyelash Thickness/Fullness as Measured Using DIA [ Time Frame: Baseline Month 4 ] [ Designated as safety issue: No ]
    Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was measured in millimeters squared (mm^2). Data from both eyes were averaged for each participant for analysis. A positive change from Baseline indicated fuller eyelashes (improvement).

  • Change From Baseline in Upper Eyelash Intensity (Darkness) as Measured Using DIA [ Time Frame: Baseline, Month 4 ] [ Designated as safety issue: No ]
    Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness (intensity) was measured in both eyes and averaged for analysis using a scale where 0=black and 255=white. A negative change from Baseline indicated darker eyelashes (improvement).

  • Percentage of Participants Satisfied or Very Satisfied in the Patient's Assessment of Overall Eyelash Satisfaction as Measured by the Eyelash Satisfaction Questionnaire (ESQ-9) [ Time Frame: Month 4 ] [ Designated as safety issue: No ]
    Participants rated their overall eyelash satisfaction by answering Eyelash Satisfaction Questionnaire (ESQ-9) question #3: "Overall, how satisfied are you with your eyelashes?" using a 5-point scale: 1= very unsatisfied (worst), 2= unsatisfied, 3= neutral, 4= satisfied or 5= very satisfied (best). The percentage of participants who rated their satisfaction as satisfied or very satisfied at Month 4 is reported.


Enrollment: 464
Study Start Date: November 2012
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: bimatoprost formulation A solution
Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Drug: bimatoprost formulation A solution
Bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Active Comparator: bimatoprost solution 0.03 %
Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Drug: bimatoprost solution 0.03 %
Bimatoprost solution 0.03 % (LATISSE®) applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Other Name: LATISSE®
Placebo Comparator: vehicle of bimatoprost formulation A solution
Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Drug: vehicle of bimatoprost formulation A solution
Vehicle of bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Placebo Comparator: vehicle of bimatoprost solution 0.03 %
Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
Drug: vehicle of bimatoprost solution 0.03 %
Vehicle of bimatoprost solution 0.03 % applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

-Male and female adult patients with eyelash hypotrichosis (inadequate eyelash growth).

Exclusion Criteria:

  • Damage to eyelid area (scarring) that may prevent growth of eyelashes
  • Active eye diseases (glaucoma, uveitis, eye infections, chronic blepharitis or severe dry eye)
  • Eye or eyelid surgery (including laser, refractive, intraocular filtering surgery, blepharoplasty) during the 3 months prior to screening
  • Current eyelash implants of any kind
  • Eyelash tint or dye application within 2 months of baseline
  • Eyelash extensions application within 3 months of baseline
  • Use of eyelash growth products within 6 months of baseline
  • Treatments that may affect hair growth (minoxidil, cancer chemotherapeutic agents, etc) within 6 months prior to baseline.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698554

Locations
United States, California
Newport Beach, California, United States
Russian Federation
St. Petersburg, Russian Federation
Sweden
Stockholm, Sweden
United Kingdom
Norfolk, England, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01698554     History of Changes
Other Study ID Numbers: 192024-046, 2012-003007-35
Study First Received: October 1, 2012
Results First Received: January 27, 2015
Last Updated: January 27, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2015