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

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ClinicalTrials.gov Identifier: NCT02848300
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Drug: Bimatoprost 1% Formulation A Drug: Bimatoprost 1% Formulation B Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Local Pharmacokinetics and Tolerability of Bimatoprost Applied Topically to the Scalp of Male Patients With Androgenetic Alopecia
Study Start Date : July 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Bimatoprost

Arm Intervention/treatment
Experimental: All Participants
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
Bimatoprost 1% Formulation A solution applied to the scalp and trunk once daily for 14 days.

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




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848300


Locations
United States, Texas
DermResearch, LLC
Austin, Texas, United States, 78759
Sponsors and Collaborators
Allergan
Investigators
Study Director: Danielle McGeeney Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02848300     History of Changes
Other Study ID Numbers: 1666-101-012
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Bimatoprost
Antihypertensive Agents