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

• ClinicalTrials.gov Identifier: NCT01189279
• Recruitment Status: Completed
• First Posted: August 26, 2010
• Results First Posted: August 30, 2013
• Last Update Posted: August 30, 2013
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

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.

Condition or disease	Intervention/treatment	Phase
Alopecia; Alopecia, Androgenetic; Baldness	Drug: bimatoprost Formulation A; Drug: bimatoprost Formulation B; Drug: bimatoprost Formulation C	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: October 2010
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: February 2011

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost [ Time Frame: 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.
2. Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost [ Time Frame: 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 :

1. Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings [ Time Frame: 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.
2. Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment [ Time Frame: 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.
3. Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• 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

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
• First Posted: August 26, 2010
• Results First Posted: August 30, 2013
• Last Update Posted: August 30, 2013
• Last Verified: June 2013

Additional relevant MeSH terms:

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