Safety, Tolerability, and Pharmacokinetics of Bimatoprost in Men With Androgenetic Alopecia (AGA)

Allergan

Status and phase: Terminated; Phase 1

Conditions: Baldness; Alopecia, Androgenetic; Alopecia

Treatments: Drug: Bimatoprost

Study type: Interventional

Funder types: Industry

Identifiers

NCT02676310

192024-085

Details and patient eligibility

About

This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic alopecia (AGA).

Enrollment: 53 patients

Sex: Male

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year

Exclusion criteria

• History of Paget's disease, osteoporosis, or bone malignancy
• History of bone fracture within the previous 12 months, except for metatarsal, metacarpal, or skull fractures
• Patient is currently undergoing radiation therapy or anticipates undergoing radiation therapy at any time during the study
• 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
• Application of topical medications, minoxidil or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

53 participants in 5 patient groups

Cohort 1: Bimatoprost 0.3% (Formulation B)

Experimental group

Description:

0.25 mL of bimatoprost 0.3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.

Treatment:

Drug: Bimatoprost

Cohort 2: Bimatoprost 1% (Formulation A)

Experimental group

Description:

0.25 mL of bimatoprost 1% (Formulation A) applied onto pre-specified area on the scalp once daily for 28 days.

Treatment:

Drug: Bimatoprost

Cohort 2: Bimatoprost 1% (Formulation B)

Experimental group

Description:

0.25 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.

Treatment:

Drug: Bimatoprost

Cohort 3: Bimatoprost 1% (Formulation B)

Experimental group

Description:

1 mL of bimatoprost 1% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.

Treatment:

Drug: Bimatoprost

Cohort 4: Bimatoprost 3% (Formulation B)

Experimental group

Description:

1 mL of bimatoprost 3% (Formulation B) applied onto pre-specified area on the scalp once daily for 28 days.

Treatment:

Drug: Bimatoprost