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Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis

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ClinicalTrials.gov Identifier: NCT01391286
Recruitment Status : Completed
First Posted : July 12, 2011
Results First Posted : July 9, 2013
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Eyelash Hypotrichosis
Interventions Drug: bimatoprost solution 0.03%
Drug: bimatoprost vehicle solution
Enrollment 36
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bimatoprost Solution 0.03% Bimatoprost Vehicle Solution
Hide Arm/Group Description One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Period Title: Overall Study
Started 18 18
Completed 18 18
Not Completed 0 0
Arm/Group Title Bimatoprost Solution 0.03% Bimatoprost Vehicle Solution Total
Hide Arm/Group Description One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months. Total of all reporting groups
Overall Number of Baseline Participants 18 18 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
< 45 Years 8 3 11
45 to 65 Years 10 12 22
> 65 Years 0 3 3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 36 participants
Female
18
 100.0%
18
 100.0%
36
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
Hide Description The investigator evaluated the patient's eyelash prominence using the GEA 4-point scale: 1= minimal, 2= moderate, 3= marked and 4= very marked at Baseline and Month 4. At least a 1-grade increase in the GEA score from Baseline indicated improvement.
Time Frame Baseline, Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population included all randomized participants.
Arm/Group Title Bimatoprost Solution 0.03% Bimatoprost Vehicle Solution
Hide Arm/Group Description:
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: Percentage of participants
88.9 27.8
2.Secondary Outcome
Title Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
Hide Description 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).
Time Frame Baseline, Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent to treat population with data available for analysis.
Arm/Group Title Bimatoprost Solution 0.03% Bimatoprost Vehicle Solution
Hide Arm/Group Description:
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Overall Number of Participants Analyzed 17 17
Median (Full Range)
Unit of Measure: mm
Baseline
5.70
(2.5 to 7.3)
5.00
(1.4 to 7.2)
Change from Baseline at Month 4
2.70
(0.6 to 6.3)
0.6
(-0.6 to 3.3)
3.Secondary Outcome
Title Change From Baseline in Eyelash Thickness as Measured by DIA
Hide Description Photographs were taken of the eyelashes and assessed using DIA. Eyelash thickness (fullness) was assessed across both eyes as an average and is measured in millimeters squared (mm^2). A positive change from Baseline indicated fuller eyelashes (improvement).
Time Frame Baseline, Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent to treat population with data available for analysis.
Arm/Group Title Bimatoprost Solution 0.03% Bimatoprost Vehicle Solution
Hide Arm/Group Description:
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Overall Number of Participants Analyzed 15 14
Median (Full Range)
Unit of Measure: mm^2
Baseline
0.60
(0.1 to 1.5)
0.45
(0.1 to 1.1)
Change from Baseline at Month 4
0.80
(0.1 to 2.0)
0.25
(-0.2 to 0.9)
4.Secondary Outcome
Title Change From Baseline in Eyelash Darkness as Measured by DIA
Hide Description Photographs were taken of the eyelashes and assessed using DIA. Eyelash darkness 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).
Time Frame Baseline, Month 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Intent to treat population with data available for analysis.
Arm/Group Title Bimatoprost Solution 0.03% Bimatoprost Vehicle Solution
Hide Arm/Group Description:
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Overall Number of Participants Analyzed 15 14
Median (Full Range)
Unit of Measure: Units on a scale
Baseline
140.15
(98.7 to 173.7)
144.98
(123.8 to 181.4)
Change from Baseline at Month 4
-19.40
(-53.4 to 3.0)
-10.03
(-23.5 to 33.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bimatoprost Solution 0.03% Bimatoprost Vehicle Solution
Hide Arm/Group Description One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months. One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
All-Cause Mortality
Bimatoprost Solution 0.03% Bimatoprost Vehicle Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bimatoprost Solution 0.03% Bimatoprost Vehicle Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   2/18 (11.11%) 
Infections and infestations     
Cellulitis  1  0/18 (0.00%)  1/18 (5.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Thyroid cancer  1  0/18 (0.00%)  1/18 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bimatoprost Solution 0.03% Bimatoprost Vehicle Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   12/18 (66.67%)   13/18 (72.22%) 
Endocrine disorders     
Hypothyroidism  1  0/18 (0.00%)  1/18 (5.56%) 
Eye disorders     
Eye pruritus  1  1/18 (5.56%)  1/18 (5.56%) 
Erythema of eyelid  1  1/18 (5.56%)  0/18 (0.00%) 
Blepharitis  1  0/18 (0.00%)  1/18 (5.56%) 
Cataract  1  0/18 (0.00%)  1/18 (5.56%) 
Dry eye  1  0/18 (0.00%)  1/18 (5.56%) 
Retinal haemorrhage  1  0/18 (0.00%)  1/18 (5.56%) 
Gastrointestinal disorders     
Colitis ischaemic  1  1/18 (5.56%)  0/18 (0.00%) 
Diarrhoea  1  1/18 (5.56%)  0/18 (0.00%) 
Periodontitis  1  1/18 (5.56%)  0/18 (0.00%) 
Vomiting  1  1/18 (5.56%)  0/18 (0.00%) 
Abdominal pain upper  1  0/18 (0.00%)  1/18 (5.56%) 
Constipation * 1  0/18 (0.00%)  1/18 (5.56%) 
General disorders     
Fatigue * 1  0/18 (0.00%)  1/18 (5.56%) 
Oedema peripheral  1  0/18 (0.00%)  1/18 (5.56%) 
Pyrexia  1  0/18 (0.00%)  1/18 (5.56%) 
Sensation of pressure * 1  0/18 (0.00%)  1/18 (5.56%) 
Infections and infestations     
Acute sinusitis  1  1/18 (5.56%)  0/18 (0.00%) 
Fungal infection  1  1/18 (5.56%)  0/18 (0.00%) 
Pharyngitis  1  1/18 (5.56%)  0/18 (0.00%) 
Nasopharyngitis  1  0/18 (0.00%)  4/18 (22.22%) 
Cellulitis  1  0/18 (0.00%)  1/18 (5.56%) 
Herpes zoster  1  0/18 (0.00%)  1/18 (5.56%) 
Paronychia  1  0/18 (0.00%)  1/18 (5.56%) 
Injury, poisoning and procedural complications     
Radiation skin injury  1  4/18 (22.22%)  2/18 (11.11%) 
Arthropod bite  1  1/18 (5.56%)  0/18 (0.00%) 
Procedural pain  1  0/18 (0.00%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/18 (5.56%)  1/18 (5.56%) 
Joint swelling  1  1/18 (5.56%)  0/18 (0.00%) 
Musculoskeletal pain * 1  1/18 (5.56%)  0/18 (0.00%) 
Musculoskeletal stiffness * 1  1/18 (5.56%)  0/18 (0.00%) 
Trigger finger  1  0/18 (0.00%)  1/18 (5.56%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Thyroid cancer  1  0/18 (0.00%)  1/18 (5.56%) 
Nervous system disorders     
Hypoaesthesia  1  1/18 (5.56%)  0/18 (0.00%) 
Peripheral sensory neuropathy  1  1/18 (5.56%)  0/18 (0.00%) 
Dizziness * 1  0/18 (0.00%)  1/18 (5.56%) 
Psychiatric disorders     
Affective disorder  1  1/18 (5.56%)  0/18 (0.00%) 
Insomnia * 1  0/18 (0.00%)  2/18 (11.11%) 
Reproductive system and breast disorders     
Pruritus genital  1  1/18 (5.56%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/18 (0.00%)  1/18 (5.56%) 
Dyspnoea  1  0/18 (0.00%)  1/18 (5.56%) 
Oropharyngeal pain  1  0/18 (0.00%)  1/18 (5.56%) 
Skin and subcutaneous tissue disorders     
Skin hyperpigmentation  1  2/18 (11.11%)  1/18 (5.56%) 
Erythema  1  1/18 (5.56%)  0/18 (0.00%) 
Dry skin  1  0/18 (0.00%)  1/18 (5.56%) 
Milia  1  0/18 (0.00%)  1/18 (5.56%) 
Rash  1  0/18 (0.00%)  1/18 (5.56%) 
Vascular disorders     
Hot flush  1  1/18 (5.56%)  0/18 (0.00%) 
Blood pressure fluctuation  1  0/18 (0.00%)  1/18 (5.56%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head,
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01391286     History of Changes
Other Study ID Numbers: 192024-067
First Submitted: July 8, 2011
First Posted: July 12, 2011
Results First Submitted: May 21, 2013
Results First Posted: July 9, 2013
Last Update Posted: July 8, 2019