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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 26, 2016
First Posted Date  ICMJE July 28, 2016
Last Update Posted Date October 26, 2016
Study Start Date  ICMJE July 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2016)
  • Drug Concentration in Skin Biopsy Samples [ Time Frame: Day 14 ]
  • Percentage of Participants with at Least 1 Treatment Emergent Adverse Event [ Time Frame: 28 Days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Local Pharmacokinetics and Tolerability of Bimatoprost Applied to the Scalp of Male Patients With Androgenetic Alopecia
Official Title  ICMJE Evaluation of Local Pharmacokinetics and Tolerability of Bimatoprost Applied Topically to the Scalp of Male Patients With Androgenetic Alopecia
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Androgenetic Alopecia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Drug: Bimatoprost 1% Formulation A
  • Drug: Bimatoprost 1% Formulation B
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2016)
11
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2016)
10
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02848300
Other Study ID Numbers  ICMJE 1666-101-012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Danielle McGeeney Allergan
PRS Account Allergan
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP