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

Primary Purpose

Alopecia, Alopecia, Androgenetic, Baldness

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Bimatoprost

About this trial

This is an interventional treatment trial for Alopecia

Eligibility Criteria

18 Years - 49 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

DermResearch, LLC
J&S Studies Inc.
E&R Research Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

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)

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02676310

First Posted

February 4, 2016

Last Updated

March 15, 2017

Sponsor

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT02676310

Brief Title

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

Official Title

Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Bimatoprost Topical Solution in the Treatment of Androgenetic Alopecia in Men

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Terminated

Study Start Date

March 2016 (undefined)

Primary Completion Date

January 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allergan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alopecia, Alopecia, Androgenetic, Baldness

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1: Bimatoprost 0.3% (Formulation B)

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 2: Bimatoprost 1% (Formulation A)

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 2: Bimatoprost 1% (Formulation B)

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 3: Bimatoprost 1% (Formulation B)

Arm Type

Experimental

Arm Description

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

Arm Title

Cohort 4: Bimatoprost 3% (Formulation B)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bimatoprost

Other Intervention Name(s)

Bimatoprost Solution applied onto pre-specified area on the scalp daily for 28 days.

Primary Outcome Measure Information:

Title

Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)

Time Frame

42 Days

Title

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

Time Frame

Baseline, 42 Days

Title

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

Time Frame

31 Days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Allergan

Official's Role

Study Director

Facility Information:

Facility Name

DermResearch, LLC

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

Facility Name

J&S Studies Inc.

City

College Station

State/Province

Texas

ZIP/Postal Code

77845

Country

United States

Facility Name

E&R Research Foundation

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24501

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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