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

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848300
• Other study ID #: 1666-101-012
• Status: Completed
• Phase: Phase 1
• First received: July 26, 2016
• Last updated: October 25, 2016
• Start date: July 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

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

Locations

Country	Name	City	State
United States	DermResearch, LLC	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug Concentration in Skin Biopsy Samples		Day 14	No
Primary	Percentage of Participants with at Least 1 Treatment Emergent Adverse Event		28 Days	No