Trial Outcomes & Findings for Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia (NCT NCT01189279)

Results Overview

Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

42 participants

Primary outcome timeframe

Day 1

Results posted on

2013-08-30

Participant Flow

Part 1 of the study was double-blind, followed by Part 2 which was open-label. No patients enrolled in Part 1 were enrolled in Part 2 of the study.

Participant milestones

Participant milestones
Measure	Part 1: Bimatoprost Formulation A bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.	Part 1: Bimatoprost Formulation B bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.	Part 2: Bimatoprost Formulation C bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
Overall Study STARTED	14	14	14
Overall Study COMPLETED	13	14	13
Overall Study NOT COMPLETED	1	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part 1: Bimatoprost Formulation A n=14 Participants bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.	Part 1: Bimatoprost Formulation B n=14 Participants bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.	Part 2: Bimatoprost Formulation C n=14 Participants bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.	Total n=42 Participants Total of all reporting groups
Age, Customized <45 years	5 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	17 Participants n=4 Participants
Age, Customized 45 to 64 years	9 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	25 Participants n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	21 Participants n=4 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	21 Participants n=4 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Per Protocol: all subjects with no major protocol deviations

Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.

Outcome measures

Outcome measures
Measure	Part 1: Bimatoprost Formulation A n=14 Participants bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.	Part 1: Bimatoprost Formulation B n=14 Participants bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.	Part 2: Bimatoprost Formulation C n=14 Participants bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost	0.552 Picograms/Milliliter (pg/mL) Standard Deviation 0.575	1.77 Picograms/Milliliter (pg/mL) Standard Deviation 1.11	5.58 Picograms/Milliliter (pg/mL) Standard Deviation 3.66

PRIMARY outcome

Timeframe: 17 Days

Population: Per Protocol: all subjects with no major protocol deviations

Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.

Outcome measures

Outcome measures
Measure	Part 1: Bimatoprost Formulation A n=13 Participants bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.	Part 1: Bimatoprost Formulation B n=14 Participants bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.	Part 2: Bimatoprost Formulation C n=13 Participants bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost	1.26 Picograms/Milliliter (pg/mL) Standard Deviation 0.60	3.01 Picograms/Milliliter (pg/mL) Standard Deviation 1.66	10.1 Picograms/Milliliter (pg/mL) Standard Deviation 7.0

SECONDARY outcome

Timeframe: 17 Days

Population: Safety Population: all subjects who received at least 1 dose of study medication

An ECG is a tracing of the heart's electrical activity over time in waves with points identified at P, Q, R, S, and T \[measured in milliseconds (ms)\], as well as the heart rate \[measured in beats per minute (bpm)\]. Clinically significant abnormal results include maximum post-treatment QTcB\>500 ms, maximum post-treatment QTcF\>500 ms, maximum post-treatment QT interval \>500 ms, PR interval 25% increase from baseline and \>200 ms, QRS interval 25% increase from baseline and \>100 ms, heart rate 25% increase from baseline and \>100 bpm, and heart rate 25% decrease from baseline and \<50 bpm.

Outcome measures

Outcome measures
Measure	Part 1: Bimatoprost Formulation A n=14 Participants bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.	Part 1: Bimatoprost Formulation B n=14 Participants bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.	Part 2: Bimatoprost Formulation C n=14 Participants bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings	0.0 Percentage of Patients 20.238	0.0 Percentage of Patients 23.460	0.0 Percentage of Patients 19.667

SECONDARY outcome

Timeframe: Baseline, 20 Days

Population: Safety Population: all subjects who received at least 1 dose of study medication

Local scalp tolerability by patient assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 3 symptoms (burning, itching, and stinging). An at least 1-grade increase from baseline at any timepoint indicates a worsening of symptoms.

Outcome measures

Outcome measures
Measure	Part 1: Bimatoprost Formulation A n=14 Participants bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.	Part 1: Bimatoprost Formulation B n=14 Participants bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.	Part 2: Bimatoprost Formulation C n=14 Participants bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment Burning	0 Patients	0 Patients	0 Patients
Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment Itching	1 Patients	0 Patients	1 Patients
Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment Stinging	0 Patients	0 Patients	0 Patients

SECONDARY outcome

Timeframe: Baseline, 20 Days

Population: Safety Population: all subjects who received at least 1 dose of study medication

Local scalp tolerability by dermatologist assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 5 symptoms (dryness/scaling, edema, erythema, folliculitis, and pigmentation). An at least 1-grade increase at any timepoint from baseline indicates a worsening of symptoms.

Outcome measures

Outcome measures
Measure	Part 1: Bimatoprost Formulation A n=14 Participants bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.	Part 1: Bimatoprost Formulation B n=14 Participants bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.	Part 2: Bimatoprost Formulation C n=14 Participants bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment Dryness/Scaling	0 Patients	1 Patients	0 Patients
Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment Edema	0 Patients	0 Patients	0 Patients
Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment Erythema	4 Patients	0 Patients	0 Patients
Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment Folliculitis	1 Patients	0 Patients	0 Patients
Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment Pigmentation	0 Patients	0 Patients	0 Patients

Adverse Events

Part 1: Bimatoprost Formulation A

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part 1: Bimatoprost Formulation B

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Part 2: Bimatoprost Formulation C

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Part 1: Bimatoprost Formulation A n=14 participants at risk bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.	Part 1: Bimatoprost Formulation B n=14 participants at risk bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.	Part 2: Bimatoprost Formulation C n=14 participants at risk bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
Nervous system disorders Headache	21.4% 3/14	7.1% 1/14	7.1% 1/14
General disorders Feeling Hot	0.00% 0/14	7.1% 1/14	0.00% 0/14
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/14	7.1% 1/14	0.00% 0/14
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/14	7.1% 1/14	0.00% 0/14
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/14	7.1% 1/14	0.00% 0/14
Nervous system disorders Somnolence	0.00% 0/14	7.1% 1/14	0.00% 0/14
Infections and infestations Application Site Folliculitis	7.1% 1/14	0.00% 0/14	0.00% 0/14
Skin and subcutaneous tissue disorders Papule	7.1% 1/14	0.00% 0/14	0.00% 0/14
Injury, poisoning and procedural complications Procedural Hypotension	7.1% 1/14	0.00% 0/14	0.00% 0/14
Skin and subcutaneous tissue disorders Pruritus	7.1% 1/14	0.00% 0/14	0.00% 0/14

Additional Information

Therapeutic Area Head,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

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