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

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.

Study Overview

• Status: Completed
• Conditions: Alopecia; Alopecia, Androgenetic; Baldness
• Intervention / Treatment: Drug: bimatoprost Formulation A; Drug: bimatoprost Formulation B; Drug: bimatoprost Formulation C

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: bimatoprost Formulation A; bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.	Drug: bimatoprost Formulation A; bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
Experimental: Part 1: bimatoprost Formulation B; bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.	Drug: bimatoprost Formulation B; bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
Experimental: Part 2: bimatoprost Formulation C; bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.	Drug: bimatoprost Formulation C; bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1
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.	17 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	17 Days
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.	Baseline, 20 Days
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.	Baseline, 20 Days

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: August 25, 2010
• First Submitted That Met QC Criteria: August 25, 2010
• First Posted (Estimate): August 26, 2010

Study Record Updates

• Last Update Posted (Estimate): August 30, 2013
• Last Update Submitted That Met QC Criteria: June 24, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Bimatoprost
• Other Study ID Numbers: 192024-053

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No