Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss

NCT01325350 | Completed Phase 2 Results

• 2 other identifiers: 192024-0582011-000380-27
• Study Type: interventional
• Target: 306
• Locations: 2 countries
• Sites: 2

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 2% solution in women with female pattern hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil 2% solution which will be provided open-label.

Conditions

Alopecia; 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). 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.

  Baseline, Month 6

Secondary Outcomes (4)

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

  Baseline, Month 6

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

  Baseline, 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 (5)

bimatoprost Formulation A

EXPERIMENTAL

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

Drug: bimatoprost Formulation A

bimatoprost Formulation B

EXPERIMENTAL

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

Drug: bimatoprost Formulation B

bimatoprost Formulation C

EXPERIMENTAL

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

Drug: bimatoprost Formulation C

bimatoprost vehicle solution

PLACEBO COMPARATOR

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

Drug: bimatoprost vehicle solution

minoxidil 2% solution

ACTIVE COMPARATOR

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

Drug: minoxidil 2% solution

Interventions

bimatoprost Formulation A DRUG

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

bimatoprost Formulation A

bimatoprost Formulation B DRUG

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

bimatoprost Formulation B

bimatoprost Formulation C DRUG

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

bimatoprost Formulation C

bimatoprost vehicle solution DRUG

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

bimatoprost vehicle solution

minoxidil 2% solution DRUG

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

Also known as: Rogaine®, Regaine®

minoxidil 2% solution

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Mild to moderate female pattern hair loss 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

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
• Oral or topical minoxidil treatment within 6 months
• Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Berlin, Germany

Location

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil; Solutions

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pharmaceutical Preparations

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, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: March 29, 2011
• Study Start: June 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 9, 2014
• Results First Posted: April 9, 2014

Record last verified: 2014-03

Locations

US (1); DE (1)