NCT02676310

Brief Summary

This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic alopecia (AGA).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 8, 2016

Completed
22 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

10 months

First QC Date

February 4, 2016

Last Update Submit

March 15, 2017

Conditions

AlopeciaAlopecia, AndrogeneticBaldness

Outcome Measures

Primary Outcomes (3)

  • Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)

    42 Days

  • Change from Baseline in Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale

    Baseline, 42 Days

  • Maximum plasma level (Cmax) of bimatoprost and its acid metabolite

    31 Days

Study Arms (5)

Cohort 1: Bimatoprost 0.3% (Formulation B)

EXPERIMENTAL

0.25 mL of bimatoprost 0.3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.

Drug: Bimatoprost

Cohort 2: Bimatoprost 1% (Formulation A)

EXPERIMENTAL

0.25 mL of bimatoprost 1% (Formulation A) applied onto pre-specified area on the scalp once daily for 28 days.

Drug: Bimatoprost

Cohort 2: Bimatoprost 1% (Formulation B)

EXPERIMENTAL

0.25 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.

Drug: Bimatoprost

Cohort 3: Bimatoprost 1% (Formulation B)

EXPERIMENTAL

1 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.

Drug: Bimatoprost

Cohort 4: Bimatoprost 3% (Formulation B)

EXPERIMENTAL

1 mL of bimatoprost 3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.

Drug: Bimatoprost

Interventions

BimatoprostDRUG
Also known as: Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.
Cohort 1: Bimatoprost 0.3% (Formulation B)Cohort 2: Bimatoprost 1% (Formulation A)Cohort 2: Bimatoprost 1% (Formulation B)Cohort 3: Bimatoprost 1% (Formulation B)Cohort 4: Bimatoprost 3% (Formulation B)

Eligibility Criteria

Age18 Years - 49 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

DermResearch, LLC

Austin, Texas, 78759, United States

Location

J&S Studies Inc.

College Station, Texas, 77845, United States

Location

E&R Research Foundation

Lynchburg, Virginia, 24501, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AmidesOrganic ChemicalsCloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 8, 2016

Study Start

March 1, 2016

Primary Completion

January 1, 2017

Study Completion

March 1, 2017

Last Updated

March 17, 2017

Record last verified: 2017-03

Locations

US(3)