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

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allergan
• Treatments: Bimatoprost

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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