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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01904721
First received: July 18, 2013
Last updated: February 23, 2016
Last verified: February 2016
  Purpose
This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).

Condition Intervention Phase
Alopecia
Alopecia, Androgenetic
Baldness
Drug: Bimatoprost Solution 1
Drug: Bimatoprost Solution 2
Drug: Bimatoprost Vehicle
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Target Area Hair Count (TAHC) [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Target Area Hair Width (TAHW) [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
    Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs).

  • Change From Baseline in Target Area Hair Darkness (TAHD) [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
    Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs ≥ 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs).


Enrollment: 244
Study Start Date: August 2013
Study Completion Date: January 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stage 1: Bimatoprost Solution 1 Twice Daily
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
Drug: Bimatoprost Solution 1
Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Experimental: Stage 1: Bimatoprost Solution 1 Once Daily
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
Drug: Bimatoprost Solution 1
Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Drug: Bimatoprost Vehicle
Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Experimental: Stage 1: Bimatoprost Solution 2 Twice Daily
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
Drug: Bimatoprost Solution 2
Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Experimental: Stage 1: Bimatoprost Solution 2 Once Daily
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
Drug: Bimatoprost Solution 2
Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Drug: Bimatoprost Vehicle
Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Experimental: Stage 2: Bimatoprost Solution 1 Twice Daily
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Drug: Bimatoprost Solution 1
Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Experimental: Stage 2: Bimatoprost Solution 2 Twice Daily
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Drug: Bimatoprost Solution 2
Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Placebo Comparator: Stage 2: Bimatoprost Vehicle Twice Daily
Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Drug: Bimatoprost Vehicle
Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Genders 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
  • 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
  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: NCT01904721

Locations
United States, Minnesota
Fridley, Minnesota, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01904721     History of Changes
Other Study ID Numbers: 192024-084 
Study First Received: July 18, 2013
Results First Received: November 4, 2015
Last Updated: February 23, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 25, 2016