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

Allergan

Status and phase: Completed; Phase 1

Conditions: Baldness; Alopecia, Androgenetic; Alopecia

Treatments: Drug: bimatoprost Formulation A; Drug: bimatoprost Formulation C; Drug: bimatoprost Formulation B

Study type: Interventional

Funder types: Industry

Identifiers

NCT01189279

192024-053

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 3 patient groups

Part 1: bimatoprost Formulation A

Experimental group

Description:

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

Treatment:

Drug: bimatoprost Formulation A

Part 1: bimatoprost Formulation B

Experimental group

Description:

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

Treatment:

Drug: bimatoprost Formulation B

Part 2: bimatoprost Formulation C

Experimental group

Description:

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

Treatment:

Drug: bimatoprost Formulation C