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Trial record 1 of 58 for:    minoxidil
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Minoxidil Response Testing in Males 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: NCT02198261
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Applied Biology, Inc.

Tracking Information
First Submitted Date July 21, 2014
First Posted Date July 23, 2014
Last Update Posted Date October 5, 2018
Study Start Date July 2014
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 22, 2014)
  • Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the mean change in non-vellus hair count in the target region [ Time Frame: baseline to week 16 ]
  • Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings [ Time Frame: baseline to week 16 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 22, 2014)
  • Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the treatment efficacy evaluated by expert panel review of global photographs assessing hair regrowth [ Time Frame: baseline to week 16 ]
  • Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the mean change in non-vellus hair diameter in the target region [ Time Frame: baseline to week 16 ]
  • Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit [ Time Frame: baseline to week 16 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Minoxidil Response Testing in Males With Androgenetic Alopecia
Official Title Minoxidil Response Testing in Males With Androgenetic Alopecia
Brief Summary

Topical minoxidil is the most common drug used for the treatment of AGA in men. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population remains relatively low i.e., 30-40% re-grow hair. To observe significant improvement in hair growth, minoxidil is typically used twice daily for a period of at least 16 weeks. Due to the significant time commitment and low response rate, a diagnostic test to identify non-responders prior to initiating therapy would be advantageous.

Minoxidil is converted in the scalp to its active form, minoxidil sulfate, by the sulfotransferase enzyme SULT1A1. The enzyme expression is variable among individuals. We have demonstrated in two prior feasibility studies that the SULT1A1 enzyme activity in plucked hair follicles correlates with minoxidil response in the treatment of AGA and thus can server as a predictive biomarker.

Consequently, we developed a minoxidil response in-vitro diagnostic kit intended to identify non-responders prior to initiating therapy with 5% topical minoxidil foam.

The primary purpose of this study is to evaluate the clinical validity of the minoxidil response in-vitro diagnostic kit.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plucked hair follicles with visible bulbs
Sampling Method Non-Probability Sample
Study Population Males with androgenetic alopecia
Condition Androgenetic Alopecia
Intervention Drug: 5% minoxidil topical foam
5% minoxidil topical foam
Other Names:
  • Rogaine 5% minoxidil foam
  • Regaine 5% minoxidil foam
Study Groups/Cohorts
  • Predicted as non-responders
    Patients that the minoxidil response in-vitro diagnostic kit predicted as non-responders. 5% minoxidil topical foam will be administered to subjects in this group.
    Intervention: Drug: 5% minoxidil topical foam
  • Predicted as responders
    Patients that the minoxidil response in-vitro diagnostic kit predicted as responders. 5% minoxidil topical foam will be administered to subjects in this group.
    Intervention: Drug: 5% minoxidil topical foam
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: July 22, 2014)
300
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2018
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Males in overall good health
  • Age: 18 to 49
  • Diagnosed with male androgenetic alopecia with vertex pattern IIIv, IV, or V on the Norwood Hamilton Scale
  • Willing to have a mini dot tattoo placed in the target area of the scalp
  • Willing to maintain the same hair style, color, shampoo and hair products use, and approximate hair length throughout the study
  • Able to give informed consent
  • Able to comply with the study requirements for 16 consecutive weeks

Exclusion Criteria:

  • Previous adverse event from topical minoxidil treatment
  • Does not use and have not used in the past 6 months anti-androgen therapy such as finasteride
  • Does not use and have not used in the past 6 months minoxidil (topical or oral)
  • Does not take medication known to cause hair thinning such as Coumadin and anti-depressants/anti-psychotics
  • Folliculitis
  • Scalp psoriasis
  • Seborrheic dermatitis
  • Inflammatory scalp conditions such as lichen planopilaris
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   India,   Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02198261
Other Study ID Numbers AB-IVD-MINOXIDIL-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Applied Biology, Inc.
Study Sponsor Applied Biology, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Sharon Keene, MD Physicians Hair Institute
Principal Investigator: Flavio Grasso, MD Istituto Medico Tricologico/Studi Life Cronos
Principal Investigator: Rodney Sinclair, MD Sinclair Dermatology
PRS Account Applied Biology, Inc.
Verification Date October 2018