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

Alopecia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01189279
• Other study ID #: 192024-053
• Status: Completed
• Phase: Phase 1
• First received: August 25, 2010
• Last updated: June 24, 2013
• Start date: October 2010
• Est. completion date: February 2011

Study information

• Verified date: June 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Alopecia, Androgenetic
• Baldness

Intervention

Drug:
• bimatoprost Formulation A
bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
• bimatoprost Formulation B
bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
• bimatoprost Formulation C
bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Day 1	No
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.	17 Days	No
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.	17 Days	No
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.	Baseline, 20 Days	No
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.	Baseline, 20 Days	No