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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01904721
First received: July 18, 2013
Last updated: May 21, 2014
Last verified: May 2014
  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 ]
  • Subject Self Assessment in Alopecia (SSA) Score on a 7-Point Scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Investigator Global Assessment (IGA) Score on a 7-Point Scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Global Panel Review (GPR) Score on a 7-Point Scale [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
  • Change from Baseline in Target Area Hair Width (TAHW) [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]
  • Change from Baseline in Target Area Hair Darkness (TAHD) [ Time Frame: Baseline, Month 6 ] [ Designated as safety issue: No ]

Enrollment: 246
Study Start Date: August 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stage 1: Bimatoprost Solution 1
Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on scalp daily for 28 days.
Drug: Bimatoprost Solution 1
Bimatoprost Solution 1 applied evenly onto pre-specified area on scalp daily for 28 days, or daily for 6 months.
Experimental: Stage 2: Bimatoprost Solution 1
Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on scalp daily for 6 months.
Drug: Bimatoprost Solution 1
Bimatoprost Solution 1 applied evenly onto pre-specified area on scalp daily for 28 days, or daily for 6 months.
Experimental: Stage 1: Bimatoprost Solution 2
Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on scalp daily for 28 days.
Drug: Bimatoprost Solution 2
Bimatoprost Solution 2 applied evenly onto pre-specified area on scalp daily for 28 days, or daily for 6 months.
Experimental: Stage 2: Bimatoprost Solution 2
Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on scalp daily for 6 months.
Drug: Bimatoprost Solution 2
Bimatoprost Solution 2 applied evenly onto pre-specified area on scalp daily for 28 days, or daily for 6 months.
Placebo Comparator: Stage 1: Bimatoprost Vehicle
Stage 1: Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on scalp daily for 28 days.
Drug: Bimatoprost Vehicle
Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on scalp daily for 28 days, or daily for 6 months.
Placebo Comparator: Stage 2: Bimatoprost Vehicle
Stage 2: Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on scalp daily for 6 months.
Drug: Bimatoprost Vehicle
Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on scalp daily for 28 days, or daily for 6 months.

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01904721     History of Changes
Other Study ID Numbers: 192024-084
Study First Received: July 18, 2013
Last Updated: May 21, 2014
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
Cloprostenol
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014