Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01325337
First received: March 28, 2011
Last updated: April 8, 2014
Last verified: April 2014

March 28, 2011
April 8, 2014
June 2011
August 2012   (final data collection date for primary outcome measure)
  • 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).
  • Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score [ Time Frame: Baseline, 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.
  • Change from Baseline in Target Area Hair Count (TAHC) Measured in Terminal Hairs/cm2 [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
  • Subject Self Assessment (SSA) Score Measuring Scalp Hair Growth Using a 7-Point Scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01325337 on ClinicalTrials.gov Archive Site
  • Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score [ Time Frame: Baseline, 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: Baseline, 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).
  • 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).
  • Investigator Global Assessment (IGA) Score Measuring Subject Scalp Hair Growth Using a 7-Point Scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Global Panel Review (GPR) Score Measuring Subject Scalp Hair Growth Using a 7-Point Scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Change from Baseline in Target Area Hair Width (TAHW) Measured in um/cm2 [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia
Not Provided

This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 5% solution in men with androgenic alopecia. All treatments will be provided in a double-blinded fashion except for minoxidil 5% solution which will be provided open-label.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Alopecia
  • Alopecia, Androgenetic
  • Baldness
  • Drug: bimatoprost Formulation A
    Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
  • Drug: bimatoprost Formulation B
    Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
  • Drug: bimatoprost Formulation C
    Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
  • Drug: bimatoprost vehicle solution
    Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
  • Drug: minoxidil 5% solution
    Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
    Other Names:
    • Rogaine®
    • Regaine®
  • Experimental: bimatoprost Formulation A
    Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
    Intervention: Drug: bimatoprost Formulation A
  • Experimental: bimatoprost Formulation B
    Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
    Intervention: Drug: bimatoprost Formulation B
  • Experimental: bimatoprost Formulation C
    Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
    Intervention: Drug: bimatoprost Formulation C
  • Placebo Comparator: bimatoprost vehicle solution
    Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
    Intervention: Drug: bimatoprost vehicle solution
  • Active Comparator: minoxidil 5% solution
    Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
    Intervention: Drug: minoxidil 5% solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
307
September 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year
  • Willingness to have micro-dot-tattoo applied to scalp
  • Willingness to maintain same hair style, length and hair color during study

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
  • Oral or topical minoxidil treatment within 6 months
  • Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks
Male
18 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT01325337
192024-057, 2011-000379-15
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
April 2014

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