Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Safety, Tolerability, and Pharmacokinetics of Bimatoprost in Men With Androgenetic Alopecia (AGA)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT02676310
First received: February 4, 2016
Last updated: March 15, 2017
Last verified: March 2017
  Purpose
This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic alopecia (AGA).

Condition Intervention Phase
Alopecia
Alopecia, Androgenetic
Baldness
Drug: Bimatoprost
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Bimatoprost Topical Solution in the Treatment of Androgenetic Alopecia in Men

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 42 Days ]
  • Change from Baseline in Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale [ Time Frame: Baseline, 42 Days ]
  • Maximum plasma level (Cmax) of bimatoprost and its acid metabolite [ Time Frame: 31 Days ]

Enrollment: 53
Study Start Date: March 2016
Study Completion Date: March 2017
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1: Bimatoprost 0.3% (Formulation B)
0.25 mL of bimatoprost 0.3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.
Drug: Bimatoprost
Other Name: Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.
Experimental: Cohort 2: Bimatoprost 1% (Formulation A)
0.25 mL of bimatoprost 1% (Formulation A) applied onto pre-specified area on the scalp once daily for 28 days.
Drug: Bimatoprost
Other Name: Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.
Experimental: Cohort 2: Bimatoprost 1% (Formulation B)
0.25 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.
Drug: Bimatoprost
Other Name: Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.
Experimental: Cohort 3: Bimatoprost 1% (Formulation B)
1 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.
Drug: Bimatoprost
Other Name: Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.
Experimental: Cohort 4: Bimatoprost 3% (Formulation B)
1 mL of bimatoprost 3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.
Drug: Bimatoprost
Other Name: Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year

Exclusion Criteria:

  • History of Paget's disease, osteoporosis, or bone malignancy
  • History of bone fracture within the previous 12 months, except for metatarsal, metacarpal, or skull fractures
  • Patient is currently undergoing radiation therapy or anticipates undergoing radiation therapy at any time during the study
  • Drug or alcohol abuse within 12 months
  • HIV positive
  • Received hair transplants or had scalp reductions
  • Use of hair weaves, hair extensions or wigs within 3 months
  • Application of topical medications, minoxidil or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
  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: NCT02676310

Locations
United States, Texas
DermResearch, LLC
Austin, Texas, United States, 78759
J&S Studies Inc.
College Station, Texas, United States, 77845
United States, Virginia
E&R Research Foundation
Lynchburg, Virginia, United States, 24501
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02676310     History of Changes
Other Study ID Numbers: 192024-085
Study First Received: February 4, 2016
Last Updated: March 15, 2017

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Bimatoprost
Antihypertensive Agents

ClinicalTrials.gov processed this record on April 28, 2017