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

NCT01904721 | Completed Phase 2 Results DMC

• 1 other identifier: 192024-084
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).

Conditions

Alopecia; Alopecia, Androgenetic; Baldness

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Target Area Hair Count (TAHC)

  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).

  Baseline, Month 6

• Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score

  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.

  Month 6

Secondary Outcomes (4)

• Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score

  Month 6

• Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score

  Month 6

• Change From Baseline in Target Area Hair Width (TAHW)

  Baseline, Month 6

• Change From Baseline in Target Area Hair Darkness (TAHD)

  Baseline, Month 6

Study Arms (7)

Stage 1: Bimatoprost Solution 1 Twice Daily

EXPERIMENTAL

Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.

Drug: Bimatoprost Solution 1

Stage 1: Bimatoprost Solution 1 Once Daily

EXPERIMENTAL

Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.

Drug: Bimatoprost Solution 1; Drug: Bimatoprost Vehicle

Stage 1: Bimatoprost Solution 2 Twice Daily

EXPERIMENTAL

Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.

Drug: Bimatoprost Solution 2

Stage 1: Bimatoprost Solution 2 Once Daily

EXPERIMENTAL

Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.

Drug: Bimatoprost Solution 2; Drug: Bimatoprost Vehicle

Stage 2: Bimatoprost Solution 1 Twice Daily

EXPERIMENTAL

Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.

Drug: Bimatoprost Solution 1

Stage 2: Bimatoprost Solution 2 Twice Daily

EXPERIMENTAL

Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.

Drug: Bimatoprost Solution 2

Stage 2: Bimatoprost Vehicle Twice Daily

PLACEBO COMPARATOR

Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.

Drug: Bimatoprost Vehicle

Interventions

Bimatoprost Solution 1 DRUG

Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Stage 1: Bimatoprost Solution 1 Once Daily; Stage 1: Bimatoprost Solution 1 Twice Daily; Stage 2: Bimatoprost Solution 1 Twice Daily

Bimatoprost Solution 2 DRUG

Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Stage 1: Bimatoprost Solution 2 Once Daily; Stage 1: Bimatoprost Solution 2 Twice Daily; Stage 2: Bimatoprost Solution 2 Twice Daily

Bimatoprost Vehicle DRUG

Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.

Stage 1: Bimatoprost Solution 1 Once Daily; Stage 1: Bimatoprost Solution 2 Once Daily; Stage 2: Bimatoprost Vehicle Twice Daily

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Fridley, Minnesota, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 22, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 22, 2016
• Results First Posted: December 9, 2015

Record last verified: 2016-02

Locations

US (1)