Minoxidil Response Testing in Males With Androgenetic Alopecia
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ClinicalTrials.gov Identifier: NCT02198261 |
Recruitment Status :
Completed
First Posted : July 23, 2014
Last Update Posted : October 5, 2018
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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 |
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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 |

Group/Cohort | Intervention/treatment |
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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.
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Drug: 5% minoxidil topical foam
5% minoxidil topical foam
Other Names:
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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.
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Drug: 5% minoxidil topical foam
5% minoxidil topical foam
Other Names:
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- 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 ]
- 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 ]
Biospecimen Retention: Samples Without DNA

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

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
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 |
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 |
Responsible Party: | Applied Biology, Inc. |
ClinicalTrials.gov Identifier: | NCT02198261 |
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 |
alopecia androgenetic alopecia hair loss |
minoxidil 5% minoxidil foam male pattern hair loss |
Alopecia Alopecia Areata Hypotrichosis Hair Diseases Skin Diseases |
Pathological Conditions, Anatomical Minoxidil Antihypertensive Agents Vasodilator Agents |