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

Tracking Information
First Submitted Date ICMJE	March 28, 2011
First Posted Date ICMJE	March 29, 2011
Results First Submitted Date	March 3, 2014
Results First Posted Date	April 10, 2014
Last Update Posted Date	April 10, 2014
Study Start Date ICMJE	June 2011
Actual Primary Completion Date	August 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 8, 2014)	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).; Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score [ Time Frame: Baseline, 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: March 28, 2011)	Change from Baseline in Target Area Hair Count (TAHC) Measured in Terminal Hairs/cm2 [ Time Frame: Baseline, Month 6 ]; Subject Self Assessment (SSA) Score Measuring Scalp Hair Growth Using a 7-Point Scale [ Time Frame: Month 6 ]
Change History	Complete list of historical versions of study NCT01325337 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 8, 2014)	Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score [ Time Frame: Baseline, 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: Baseline, 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).; 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).
Original Secondary Outcome Measures ICMJE; (submitted: March 28, 2011)	Investigator Global Assessment (IGA) Score Measuring Subject Scalp Hair Growth Using a 7-Point Scale [ Time Frame: Month 6 ]; Global Panel Review (GPR) Score Measuring Subject Scalp Hair Growth Using a 7-Point Scale [ Time Frame: Month 6 ]; Change from Baseline in Target Area Hair Width (TAHW) Measured in um/cm2 [ Time Frame: Baseline, Month 6 ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety and Efficacy Study of Bimatoprost in the Treatment of Men With Androgenic Alopecia
Official Title ICMJE	Not Provided
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Alopecia; Alopecia, Androgenetic; Baldness
Intervention ICMJE	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®
Study Arms	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
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 5, 2012)	307
Original Estimated Enrollment ICMJE; (submitted: March 28, 2011)	300
Actual Study Completion Date	September 2012
Actual Primary Completion Date	August 2012 (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 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
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years to 49 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Germany, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01325337
Other Study ID Numbers ICMJE	192024-057; 2011-000379-15 ( EudraCT Number )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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	April 2014
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP