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Completed

NCT Number: NCT02848300

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

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).

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Key information

Conditions

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

Age range

18 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

DermResearch, LLC

Austin, Texas, 78759, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bimatoprost 1% Formulation A

Drug

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

Bimatoprost 1% Formulation B

Drug

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

Primary outcomes

  1. Drug Concentration in Skin Biopsy Samples

    Time frame: Day 14

  2. Percentage of Participants with at Least 1 Treatment Emergent Adverse Event

    Time frame: 28 Days

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 28, 2016
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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