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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5% minoxidil topical foam | Drug | 5% minoxidil topical foam |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline to week 16 | |
| Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings | baseline to week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Males with androgenetic alopecia
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| Name | Affiliation | Role |
|---|---|---|
| Sharon Keene, MD | Physicians Hair Institute | Principal Investigator |
| Flavio Grasso, MD | Istituto Medico Tricologico/Studi Life Cronos | Principal Investigator |
| Rodney Sinclair, MD | Sinclair Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physicians Hair Institute | Tucson | Arizona | 85719 | United States | ||
| Tennessee Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24773771 | Background | Roberts J, Desai N, McCoy J, Goren A. Sulfotransferase activity in plucked hair follicles predicts response to topical minoxidil in the treatment of female androgenetic alopecia. Dermatol Ther. 2014 Jul-Aug;27(4):252-4. doi: 10.1111/dth.12130. Epub 2014 Apr 28. | |
| 24283387 | Background | Goren A, Castano JA, McCoy J, Bermudez F, Lotti T. Novel enzymatic assay predicts minoxidil response in the treatment of androgenetic alopecia. Dermatol Ther. 2014 May-Jun;27(3):171-3. doi: 10.1111/dth.12111. Epub 2013 Nov 27. |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D008914 | Minoxidil |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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Plucked hair follicles with visible bulbs
| baseline to week 16 |
| Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit | baseline to week 16 |
| Nashville |
| Tennessee |
| 37215 |
| United States |
| Sinclair Dermatology | East Melbourne | 3002 | Australia |
| LTM Medical College & Hospital | Mumbai | 400022 | India |
| Istituto Medico Tricologico/Studi Life Cronos | Florence | 50127 | Italy |
| 2230218 | Background | Buhl AE, Waldon DJ, Baker CA, Johnson GA. Minoxidil sulfate is the active metabolite that stimulates hair follicles. J Invest Dermatol. 1990 Nov;95(5):553-7. doi: 10.1111/1523-1747.ep12504905. |
| 14996087 | Background | Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004 Feb;150(2):186-94. doi: 10.1111/j.1365-2133.2004.05785.x. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |