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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01189279
First received: August 25, 2010
Last updated: June 24, 2013
Last verified: June 2013
  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:


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
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

No publications provided

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
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014