Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Alopecia Alopecia, Androgenetic Baldness	Drug: bimatoprost Formulation A Drug: bimatoprost Formulation B Drug: bimatoprost Formulation C	Phase 1


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

Resource links provided by NLM:

Drug Information available for: Bimatoprost

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
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 [ Time Frame: 17 Days ] [ Designated as safety issue: No ]
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 [ Time Frame: 17 Days ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, 20 Days ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, 20 Days ] [ Designated as safety issue: No ]
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.


Enrollment:	42
Study Start Date:	October 2010
Study Completion Date:	February 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	18 Years to 64 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01189279

Locations


United States, Arizona

Tempe, Arizona, United States

Sponsors and Collaborators

Allergan

Investigators


Study Director:	Medical Director	Allergan

More Information


Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01189279 History of Changes
Other Study ID Numbers:	192024-053
Study First Received:	August 25, 2010
Results First Received:	June 24, 2013
Last Updated:	June 24, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Alopecia Alopecia Areata Hypotrichosis Hair Diseases	Skin Diseases Pathological Conditions, Anatomical Bimatoprost Antihypertensive Agents

ClinicalTrials.gov processed this record on September 23, 2016