ClinicalTrials.gov
ClinicalTrials.gov Menu

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.

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.


Condition or disease Intervention/treatment
Androgenetic Alopecia Drug: 5% minoxidil topical foam

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Minoxidil Response Testing in Males With Androgenetic Alopecia
Study Start Date : July 2014
Actual Primary Completion Date : October 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Minoxidil

Group/Cohort Intervention/treatment
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.
Drug: 5% minoxidil topical foam
5% minoxidil topical foam
Other Names:
  • Rogaine 5% minoxidil foam
  • Regaine 5% minoxidil 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.
Drug: 5% minoxidil topical foam
5% minoxidil topical foam
Other Names:
  • Rogaine 5% minoxidil foam
  • Regaine 5% minoxidil foam




Primary Outcome Measures :
  1. 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 ]
  2. Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings [ Time Frame: baseline to week 16 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Biospecimen Retention:   Samples Without DNA
Plucked hair follicles with visible bulbs


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Males with androgenetic alopecia
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

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): NCT02198261


Locations
United States, Arizona
Physicians Hair Institute
Tucson, Arizona, United States, 85719
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
Australia
Sinclair Dermatology
East Melbourne, Australia, 3002
India
LTM Medical College & Hospital
Mumbai, India, 400022
Italy
Istituto Medico Tricologico/Studi Life Cronos
Florence, Italy, 50127
Sponsors and Collaborators
Applied Biology, Inc.
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

Publications:
Responsible Party: Applied Biology, Inc.
ClinicalTrials.gov Identifier: NCT02198261     History of Changes
Other Study ID Numbers: AB-IVD-MINOXIDIL-003
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

Keywords provided by Applied Biology, Inc.:
alopecia
androgenetic alopecia
hair loss
minoxidil
5% minoxidil foam
male pattern hair loss

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