Trial Outcomes & Findings for Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis (NCT NCT01391286)
NCT ID: NCT01391286
Last Updated: 2019-07-08
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
36 participants
Primary outcome timeframe
Baseline, Month 4
Results posted on
2019-07-08
Participant Flow
Participant milestones
| Measure |
Bimatoprost Solution 0.03%
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
|
Bimatoprost Vehicle Solution
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis
Baseline characteristics by cohort
| Measure |
Bimatoprost Solution 0.03%
n=18 Participants
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
|
Bimatoprost Vehicle Solution
n=18 Participants
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
< 45 Years
|
8 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Age, Customized
45 to 65 Years
|
10 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Age, Customized
> 65 Years
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 4Population: Intent to treat population included all randomized participants.
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.
Outcome measures
| Measure |
Bimatoprost Solution 0.03%
n=18 Participants
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
|
Bimatoprost Vehicle Solution
n=18 Participants
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
|
|---|---|---|
|
Percentage of Participants With at Least a 1-Grade Increase in Overall Eyelash Prominence Using the Global Eyelash Assessment Scale (GEA)
|
88.9 Percentage of participants
|
27.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 4Population: Participants from the Intent to treat population with data available for analysis.
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).
Outcome measures
| Measure |
Bimatoprost Solution 0.03%
n=17 Participants
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
|
Bimatoprost Vehicle Solution
n=17 Participants
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
|
|---|---|---|
|
Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
Baseline
|
5.70 mm
Full Range 1.397 • Interval 2.5 to 7.3
|
5.00 mm
Full Range 1.543 • Interval 1.4 to 7.2
|
|
Change From Baseline in Eyelash Length as Measured by Digital Image Analysis (DIA)
Change from Baseline at Month 4
|
2.70 mm
Full Range 1.574 • Interval 0.6 to 6.3
|
0.6 mm
Full Range 1.317 • Interval -0.6 to 3.3
|
SECONDARY outcome
Timeframe: Baseline, Month 4Population: Participants from the Intent to treat population with data available for analysis.
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).
Outcome measures
| Measure |
Bimatoprost Solution 0.03%
n=15 Participants
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
|
Bimatoprost Vehicle Solution
n=14 Participants
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
|
|---|---|---|
|
Change From Baseline in Eyelash Thickness as Measured by DIA
Baseline
|
0.60 mm^2
Full Range 0.456 • Interval 0.1 to 1.5
|
0.45 mm^2
Full Range 0.294 • Interval 0.1 to 1.1
|
|
Change From Baseline in Eyelash Thickness as Measured by DIA
Change from Baseline at Month 4
|
0.80 mm^2
Full Range 0.460 • Interval 0.1 to 2.0
|
0.25 mm^2
Full Range 0.393 • Interval -0.2 to 0.9
|
SECONDARY outcome
Timeframe: Baseline, Month 4Population: Participants from the Intent to treat population with data available for analysis.
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).
Outcome measures
| Measure |
Bimatoprost Solution 0.03%
n=15 Participants
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
|
Bimatoprost Vehicle Solution
n=14 Participants
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
|
|---|---|---|
|
Change From Baseline in Eyelash Darkness as Measured by DIA
Baseline
|
140.15 Units on a scale
Full Range 21.855 • Interval 98.7 to 173.7
|
144.98 Units on a scale
Full Range 18.561 • Interval 123.8 to 181.4
|
|
Change From Baseline in Eyelash Darkness as Measured by DIA
Change from Baseline at Month 4
|
-19.40 Units on a scale
Full Range 12.666 • Interval -53.4 to 3.0
|
-10.03 Units on a scale
Full Range 18.248 • Interval -23.5 to 33.6
|
Adverse Events
Bimatoprost Solution 0.03%
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Bimatoprost Vehicle Solution
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bimatoprost Solution 0.03%
n=18 participants at risk
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
|
Bimatoprost Vehicle Solution
n=18 participants at risk
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/18
|
5.6%
1/18
|
|
Infections and infestations
Cellulitis
|
0.00%
0/18
|
5.6%
1/18
|
Other adverse events
| Measure |
Bimatoprost Solution 0.03%
n=18 participants at risk
One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
|
Bimatoprost Vehicle Solution
n=18 participants at risk
One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
|
|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/18
|
5.6%
1/18
|
|
Eye disorders
Eye pruritus
|
5.6%
1/18
|
5.6%
1/18
|
|
Eye disorders
Erythema of eyelid
|
5.6%
1/18
|
0.00%
0/18
|
|
Eye disorders
Blepharitis
|
0.00%
0/18
|
5.6%
1/18
|
|
Eye disorders
Cataract
|
0.00%
0/18
|
5.6%
1/18
|
|
Eye disorders
Dry eye
|
0.00%
0/18
|
5.6%
1/18
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/18
|
5.6%
1/18
|
|
Gastrointestinal disorders
Colitis ischaemic
|
5.6%
1/18
|
0.00%
0/18
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
1/18
|
0.00%
0/18
|
|
Gastrointestinal disorders
Periodontitis
|
5.6%
1/18
|
0.00%
0/18
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18
|
0.00%
0/18
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/18
|
5.6%
1/18
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18
|
5.6%
1/18
|
|
General disorders
Fatigue
|
0.00%
0/18
|
5.6%
1/18
|
|
General disorders
Oedema peripheral
|
0.00%
0/18
|
5.6%
1/18
|
|
General disorders
Pyrexia
|
0.00%
0/18
|
5.6%
1/18
|
|
General disorders
Sensation of pressure
|
0.00%
0/18
|
5.6%
1/18
|
|
Infections and infestations
Acute sinusitis
|
5.6%
1/18
|
0.00%
0/18
|
|
Infections and infestations
Fungal infection
|
5.6%
1/18
|
0.00%
0/18
|
|
Infections and infestations
Pharyngitis
|
5.6%
1/18
|
0.00%
0/18
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/18
|
22.2%
4/18
|
|
Infections and infestations
Cellulitis
|
0.00%
0/18
|
5.6%
1/18
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/18
|
5.6%
1/18
|
|
Infections and infestations
Paronychia
|
0.00%
0/18
|
5.6%
1/18
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
22.2%
4/18
|
11.1%
2/18
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.6%
1/18
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/18
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18
|
5.6%
1/18
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.6%
1/18
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.6%
1/18
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
5.6%
1/18
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/18
|
5.6%
1/18
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/18
|
5.6%
1/18
|
|
Nervous system disorders
Hypoaesthesia
|
5.6%
1/18
|
0.00%
0/18
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
1/18
|
0.00%
0/18
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18
|
5.6%
1/18
|
|
Psychiatric disorders
Affective disorder
|
5.6%
1/18
|
0.00%
0/18
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18
|
11.1%
2/18
|
|
Reproductive system and breast disorders
Pruritus genital
|
5.6%
1/18
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/18
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/18
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
11.1%
2/18
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
1/18
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/18
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Milia
|
0.00%
0/18
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/18
|
5.6%
1/18
|
|
Vascular disorders
Hot flush
|
5.6%
1/18
|
0.00%
0/18
|
|
Vascular disorders
Blood pressure fluctuation
|
0.00%
0/18
|
5.6%
1/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER