A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)

Phase 2CompletedNCT01904721

Allergan244 enrolled

Overview

This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

244

Conditions

Alopecia Alopecia, Androgenetic Baldness

Interventions

Bimatoprost Solution 1DRUG

Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Bimatoprost Solution 2DRUG

Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Bimatoprost VehicleDRUG

Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 49 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year * Willingness to maintain same hair style, length and hair color during study * Willingness to have micro-dot-tattoo applied to scalp (Stage 2 only) Exclusion Criteria: * 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 * Use of minoxidil (oral or topical) and/or low level light treatment "combs" for hair growth within the last 6 months, or expected use during the study * Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks

Locations (1)

Unnamed facility

Fridley, Minnesota, United States

Outcomes

Primary Outcomes

Change From Baseline in Target Area Hair Count (TAHC)

TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm\^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).

Time frame: Baseline, Month 6

Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score

The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.

Time frame: Month 6

Secondary Outcomes

Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score

The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: "Since the start of the study, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.

Time frame: Month 6

Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score

At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: "Compared with the baseline image, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.

Data from ClinicalTrials.gov

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