Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia

NCT01189279 | Completed Phase 1 Results

• 1 other identifier: 192024-053
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the safety, tolerability, and pharmacokinetics of new formulation of bimatoprost following topical application in patients with alopecia. Two formulations of bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be investigated in Part 2. Part 2 will begin after Part 1 has completed.

Conditions

Alopecia; Alopecia, Androgenetic; Baldness

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost

  Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.

  Day 1

• Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost

  Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.

  17 Days

Secondary Outcomes (3)

• Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings

  17 Days

• Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment

  Baseline, 20 Days

• Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment

  Baseline, 20 Days

Study Arms (3)

Part 1: bimatoprost Formulation A

EXPERIMENTAL

bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.

Drug: bimatoprost Formulation A

Part 1: bimatoprost Formulation B

EXPERIMENTAL

bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.

Drug: bimatoprost Formulation B

Part 2: bimatoprost Formulation C

EXPERIMENTAL

bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.

Drug: bimatoprost Formulation C

Interventions

bimatoprost Formulation A DRUG

bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.

Part 1: bimatoprost Formulation A

bimatoprost Formulation B DRUG

bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.

Part 1: bimatoprost Formulation B

bimatoprost Formulation C DRUG

bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.

Part 2: bimatoprost Formulation C

Eligibility Criteria

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

You may qualify if:

• Males with moderate male-pattern baldness (androgenic alopecia)
• Females with moderate female pattern hair loss
• Non-smoker or smoker with at least 30 days abstinence from smoking/using nicotine-containing products

You may not qualify if:

• Any dermatological condition of the scalp other than androgenic alopecia (males) or female pattern hair loss (females)
• Use of bimatoprost or other prostaglandin analogs within 3 months
• Prior use of scalp hair growth treatment (eg, finasteride, minoxidil) within 6 months
• Any prior hair growth procedures (eg, hair transplant or laser)
• Blood donation or equivalent blood loss within 90 days
• History of alcohol or drug addiction

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Tempe, Arizona, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

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

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 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 26, 2010
• Study Start: October 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: August 30, 2013
• Results First Posted: August 30, 2013

Record last verified: 2013-06

Locations

US (1)