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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: April 11, 2012
Last verified: April 2012
History of Changes
  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:
  • Pharmacokinetics following single dose of bimatoprost [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Pharmacokinetics following multiple doses of bimatoprost [ Time Frame: Day 17 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 12-Lead Electrocardiogram (ECG) [ Time Frame: Day 17 ] [ Designated as safety issue: No ]
  • Local Scalp Tolerability Assessment [ Time Frame: Day 20 ] [ Designated as safety issue: No ]

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
 Drug: bimatoprost Formulation A
One mL dose applied evenly onto pre-specified balding area on scalp - single dose in the am followed by multiple doses daily in the am for 14 days
Experimental: Part 1: bimatoprost Formulation B
bimatoprost Formulation B
 Drug: bimatoprost Formulation B
One mL dose applied evenly onto pre-specified balding area on scalp - single dose in the am, followed by multiple doses daily in the am for 14 days
Experimental: Part 2: bimatoprost Formulation C
bimatoprost Formulation C
 Drug: bimatoprost Formulation C
One mL dose applied evenly onto pre-specified balding area on scalp - single dose in the am, followed by multiple doses daily in the am for 14 days

  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
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
Last Updated: April 11, 2012
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 May 16, 2013