Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia
- Conditions
- AlopeciaAlopecia, AndrogeneticBaldness
- Interventions
- Registration Number
- NCT01189279
- Lead Sponsor
- Allergan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: bimatoprost Formulation A 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 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 bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.