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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02676310
First Posted: February 8, 2016
Last Update Posted: March 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  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: None (Open Label)
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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: February 4, 2016
First Posted: February 8, 2016
Last Update Posted: March 17, 2017
Last Verified: March 2017

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