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

NCT02848300 | Completed Phase 1

• 1 other identifier: 1666-101-012
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (2)

• Drug Concentration in Skin Biopsy Samples

  Day 14

• Percentage of Participants with at Least 1 Treatment Emergent Adverse Event

  28 Days

Study Arms (1)

All Participants

EXPERIMENTAL

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.

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

Interventions

Bimatoprost 1% Formulation A DRUG

Bimatoprost 1% Formulation A solution applied to the scalp and trunk once daily for 14 days.

All Participants

Bimatoprost 1% Formulation B DRUG

Bimatoprost 1% Formulation B solution applied to the scalp and trunk once daily for 14 days.

All Participants

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

DermResearch, LLC

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Bimatoprost

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amides; Organic Chemicals; Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Danielle McGeeney

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: July 28, 2016
• Study Start: July 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 26, 2016

Record last verified: 2016-10

Locations

US (1)