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

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.
 
ClinicalTrials.gov Identifier: NCT01904721
Recruitment Status : Completed
First Posted : July 22, 2013
Results First Posted : December 9, 2015
Last Update Posted : March 22, 2016
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE July 18, 2013
First Posted Date  ICMJE July 22, 2013
Results First Submitted Date  ICMJE November 4, 2015
Results First Posted Date  ICMJE December 9, 2015
Last Update Posted Date March 22, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
  • Change From Baseline in Target Area Hair Count (TAHC) [ Time Frame: Baseline, Month 6 ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
  • Change from Baseline in Target Area Hair Count (TAHC) [ Time Frame: Baseline, Month 6 ]
  • Subject Self Assessment in Alopecia (SSA) Score on a 7-Point Scale [ Time Frame: Month 6 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2015)
  • Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score [ Time Frame: Month 6 ]
    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 ]
    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 ]
    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 ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
  • Investigator Global Assessment (IGA) Score on a 7-Point Scale [ Time Frame: Month 6 ]
  • Global Panel Review (GPR) Score on a 7-Point Scale [ Time Frame: Month 6 ]
  • Change from Baseline in Target Area Hair Width (TAHW) [ Time Frame: Baseline, Month 6 ]
  • Change from Baseline in Target Area Hair Darkness (TAHD) [ Time Frame: Baseline, Month 6 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)
Official Title  ICMJE Not Provided
Brief Summary This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Alopecia
  • Alopecia, Androgenetic
  • Baldness
Intervention  ICMJE
  • 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 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Bimatoprost Solution 1
  • 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.
    Interventions:
    • Drug: Bimatoprost Solution 1
    • Drug: Bimatoprost Vehicle
  • 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.
    Intervention: Drug: Bimatoprost Solution 2
  • 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.
    Interventions:
    • Drug: Bimatoprost Solution 2
    • Drug: Bimatoprost Vehicle
  • 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.
    Intervention: Drug: Bimatoprost Solution 1
  • 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.
    Intervention: Drug: Bimatoprost Solution 2
  • 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.
    Intervention: Drug: Bimatoprost Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2015)
244
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2013)
228
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01904721
Other Study ID Numbers  ICMJE 192024-084
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP