Back to resultsSafety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia
Primary Purpose
Alopecia, Alopecia, Androgenetic, Baldness
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
bimatoprost Formulation A
bimatoprost Formulation B
bimatoprost Formulation C
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Part 1: bimatoprost Formulation A
Part 1: bimatoprost Formulation B
Part 2: bimatoprost Formulation C
Arm Description
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.
bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01189279
Brief Title
Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia, Alopecia, Androgenetic, Baldness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 1: bimatoprost Formulation A
Arm Type
Experimental
Arm Description
bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
Arm Title
Part 1: bimatoprost Formulation B
Arm Type
Experimental
Arm Description
bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
Arm Title
Part 2: bimatoprost Formulation C
Arm Type
Experimental
Arm Description
bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
Intervention Type
Drug
Intervention Name(s)
bimatoprost Formulation A
Intervention Description
bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
Intervention Type
Drug
Intervention Name(s)
bimatoprost Formulation B
Intervention Description
bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
Intervention Type
Drug
Intervention Name(s)
bimatoprost Formulation C
Intervention Description
bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
Primary Outcome Measure Information:
Title
Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost
Description
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
Title
Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost
Description
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
Secondary Outcome Measure Information:
Title
Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings
Description
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
Title
Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment
Description
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
Title
Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Tempe
State/Province
Arizona
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia
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