Local Pharmacokinetics and Tolerability of Bimatoprost Applied to the Scalp of Male Patients With Androgenetic Alopecia

Allergan

Status and phase: Completed; Phase 1

Conditions: Androgenetic Alopecia

Treatments: Drug: Bimatoprost 1% Formulation A; Drug: Bimatoprost 1% Formulation B

Study type: Interventional

Funder types: Industry

Identifiers

NCT02848300

1666-101-012

Details and patient eligibility

About

This study will evaluate the skin pharmacokinetics and tolerability of bimatoprost Formulation A and Formulation B following 14 days of once daily topical administration in male participants with androgenetic alopecia (AGA).

Full description

Single-center, multiple-dose study evaluting the local pharmacokinetics and tolerability of bimatoprost following 14 days of once daily topical administration of bimatoprost Formulation A and Formulation B (both containing 1% bimatoprost) to the scalp of male patients With androgenetic alopecia

Enrollment: 11 patients

Sex: Male

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Patients with mild to moderate Androgenetic Alopecia of the vertex area of the scalp.

Exclusion criteria

• Patients with uncontrolled systemic disease
• History of significant cardiovascular disease
• Scarring disease, infection, or abnormality of the scalp or hair shaft or systemic disease that could cause temporary hair loss (eg, seborrheic dermatitis, psoriatic dermatitis, alopecia areata, cicatricial alopecia, uncontrolled hyperthyroidism/hypothyroidism, tinea infections, and genetic disorders)
• Patients who have received hair transplants or have had scalp reductions
• Abnormal bone biomarker laboratory results.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

All Participants

Experimental group

Description:

Bimatoprost 1% Formulation A solution applied to the left side of the scalp and trunk area and Bimatoprost 1% Formulation B solution applied to the right side of the scalp and trunk area once daily for 14 days.

Treatment:

Drug: Bimatoprost 1% Formulation B

Drug: Bimatoprost 1% Formulation A