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

Phase 1

Completed

• Conditions: Androgenetic Alopecia
• Interventions: Drug: Bimatoprost 1% Formulation A; Drug: Bimatoprost 1% Formulation B

• Registration Number: NCT02848300
• Lead Sponsor: Allergan

Brief Summary

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).

Detailed 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

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-28
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Participants	Bimatoprost 1% Formulation A	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.
All Participants	Bimatoprost 1% Formulation B	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.

Primary Outcome Measures

Name	Time	Method
Drug Concentration in Skin Biopsy Samples	Day 14
Percentage of Participants with at Least 1 Treatment Emergent Adverse Event	28 Days

Trial Locations

Locations (1)

DermResearch, LLC; 🇺🇸 Austin, Texas, United States