Alopecia, Alopecia, Androgenetic, Baldness
Conditions
Brief summary
This study will investigate the safety, tolerability, and pharmacokinetics of new formulation of bimatoprost following topical application in patients with alopecia. Two formulations of bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be investigated in Part 2. Part 2 will begin after Part 1 has completed.
Interventions
bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Males with moderate male-pattern baldness (androgenic alopecia) * Females with moderate female pattern hair loss * Non-smoker or smoker with at least 30 days abstinence from smoking/using nicotine-containing products
Exclusion criteria
* Any dermatological condition of the scalp other than androgenic alopecia (males) or female pattern hair loss (females) * Use of bimatoprost or other prostaglandin analogs within 3 months * Prior use of scalp hair growth treatment (eg, finasteride, minoxidil) within 6 months * Any prior hair growth procedures (eg, hair transplant or laser) * Blood donation or equivalent blood loss within 90 days * History of alcohol or drug addiction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost | Day 1 | 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. |
| Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost | 17 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings | 17 Days | 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. |
| Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment | Baseline, 20 Days | 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. |
| Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Baseline, 20 Days | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Part 1: Bimatoprost Formulation A bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17. | 14 |
| Part 1: Bimatoprost Formulation B bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17. | 14 |
| Part 2: Bimatoprost Formulation C bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17. | 14 |
| Total | 42 |
Baseline characteristics
| Characteristic | Total | Part 1: Bimatoprost Formulation A | Part 1: Bimatoprost Formulation B | Part 2: Bimatoprost Formulation C |
|---|---|---|---|---|
| Age, Customized 45 to 64 years | 25 Participants | 9 Participants | 10 Participants | 6 Participants |
| Age, Customized <45 years | 17 Participants | 5 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Female | 21 Participants | 7 Participants | 7 Participants | 7 Participants |
| Sex: Female, Male Male | 21 Participants | 7 Participants | 7 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 14 | 6 / 14 | 1 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 14 |
Outcome results
Primary
Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost
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.
Time frame: Day 1
Population: Per Protocol: all subjects with no major protocol deviations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Bimatoprost Formulation A | Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost | 0.552 Picograms/Milliliter (pg/mL) | Standard Deviation 0.575 |
| Part 1: Bimatoprost Formulation B | Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost | 1.77 Picograms/Milliliter (pg/mL) | Standard Deviation 1.11 |
| Part 2: Bimatoprost Formulation C | Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost | 5.58 Picograms/Milliliter (pg/mL) | Standard Deviation 3.66 |
Primary
Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost
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.
Time frame: 17 Days
Population: Per Protocol: all subjects with no major protocol deviations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Part 1: Bimatoprost Formulation A | Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost | 1.26 Picograms/Milliliter (pg/mL) | Standard Deviation 0.6 |
| Part 1: Bimatoprost Formulation B | Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost | 3.01 Picograms/Milliliter (pg/mL) | Standard Deviation 1.66 |
| Part 2: Bimatoprost Formulation C | Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost | 10.1 Picograms/Milliliter (pg/mL) | Standard Deviation 7 |
Secondary
Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment
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.
Time frame: Baseline, 20 Days
Population: Safety Population: all subjects who received at least 1 dose of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Bimatoprost Formulation A | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Folliculitis | 1 Patients |
| Part 1: Bimatoprost Formulation A | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Erythema | 4 Patients |
| Part 1: Bimatoprost Formulation A | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Dryness/Scaling | 0 Patients |
| Part 1: Bimatoprost Formulation A | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Edema | 0 Patients |
| Part 1: Bimatoprost Formulation A | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Pigmentation | 0 Patients |
| Part 1: Bimatoprost Formulation B | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Erythema | 0 Patients |
| Part 1: Bimatoprost Formulation B | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Dryness/Scaling | 1 Patients |
| Part 1: Bimatoprost Formulation B | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Edema | 0 Patients |
| Part 1: Bimatoprost Formulation B | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Folliculitis | 0 Patients |
| Part 1: Bimatoprost Formulation B | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Pigmentation | 0 Patients |
| Part 2: Bimatoprost Formulation C | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Pigmentation | 0 Patients |
| Part 2: Bimatoprost Formulation C | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Folliculitis | 0 Patients |
| Part 2: Bimatoprost Formulation C | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Dryness/Scaling | 0 Patients |
| Part 2: Bimatoprost Formulation C | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Erythema | 0 Patients |
| Part 2: Bimatoprost Formulation C | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment | Edema | 0 Patients |
Secondary
Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment
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.
Time frame: Baseline, 20 Days
Population: Safety Population: all subjects who received at least 1 dose of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: Bimatoprost Formulation A | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment | Itching | 1 Patients |
| Part 1: Bimatoprost Formulation A | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment | Burning | 0 Patients |
| Part 1: Bimatoprost Formulation A | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment | Stinging | 0 Patients |
| Part 1: Bimatoprost Formulation B | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment | Itching | 0 Patients |
| Part 1: Bimatoprost Formulation B | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment | Burning | 0 Patients |
| Part 1: Bimatoprost Formulation B | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment | Stinging | 0 Patients |
| Part 2: Bimatoprost Formulation C | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment | Burning | 0 Patients |
| Part 2: Bimatoprost Formulation C | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment | Stinging | 0 Patients |
| Part 2: Bimatoprost Formulation C | Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment | Itching | 1 Patients |
Secondary
Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings
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.
Time frame: 17 Days
Population: Safety Population: all subjects who received at least 1 dose of study medication
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Part 1: Bimatoprost Formulation A | Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings | 0.0 Percentage of Patients | 20.238 |
| Part 1: Bimatoprost Formulation B | Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings | 0.0 Percentage of Patients | 23.46 |
| Part 2: Bimatoprost Formulation C | Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings | 0.0 Percentage of Patients | 19.667 |