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Completed

NCT Number: NCT01325337

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

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.

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Key information

Conditions

Alopecia Alopecia, Androgenetic Baldness Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bimatoprost Formulation A

Drug

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

bimatoprost Formulation B

Drug

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

bimatoprost Formulation C

Drug

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

bimatoprost vehicle solution

Drug

Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.

minoxidil 5% solution

Drug

Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.

Other names: Rogaine®, Regaine®

Primary outcomes

  1. 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).

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 29, 2011
Registry last updated
Apr 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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