Back to resultsLocal Pharmacokinetics and Tolerability of Bimatoprost Applied to the Scalp of Male Patients With Androgenetic Alopecia
Primary Purpose
Androgenetic Alopecia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bimatoprost 1% Formulation A
Bimatoprost 1% Formulation B
Sponsored by
About this trial
This is an interventional basic science trial for Androgenetic Alopecia
Eligibility Criteria
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.
Sites / Locations
- DermResearch, LLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All Participants
Arm 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.
Outcomes
Primary Outcome Measures
Drug Concentration in Skin Biopsy Samples
Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02848300
Brief Title
Local Pharmacokinetics and Tolerability of Bimatoprost Applied to the Scalp of Male Patients With Androgenetic Alopecia
Official Title
Evaluation of Local Pharmacokinetics and Tolerability of Bimatoprost Applied Topically to the Scalp of Male Patients With Androgenetic Alopecia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All Participants
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost 1% Formulation A
Intervention Description
Bimatoprost 1% Formulation A solution applied to the scalp and trunk once daily for 14 days.
Intervention Type
Drug
Intervention Name(s)
Bimatoprost 1% Formulation B
Intervention Description
Bimatoprost 1% Formulation B solution applied to the scalp and trunk once daily for 14 days.
Primary Outcome Measure Information:
Title
Drug Concentration in Skin Biopsy Samples
Time Frame
Day 14
Title
Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
Time Frame
28 Days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle McGeeney
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
DermResearch, LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Local Pharmacokinetics and Tolerability of Bimatoprost Applied to the Scalp of Male Patients With Androgenetic Alopecia
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