- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02198261
Minoxidil Response Testing in Males With Androgenetic Alopecia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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East Melbourne, Australia, 3002
- Sinclair Dermatology
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Mumbai, India, 400022
- LTM Medical College & Hospital
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Florence, Italy, 50127
- Istituto Medico Tricologico/Studi Life Cronos
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Arizona
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Tucson, Arizona, United States, 85719
- Physicians Hair Institute
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Tennessee
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Nashville, Tennessee, United States, 37215
- Tennessee Clinical Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
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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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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5% minoxidil topical foam
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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baseline to week 16
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Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings
Time Frame: baseline to week 16
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baseline to week 16
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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
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baseline to week 16
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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 diameter in the target region
Time Frame: baseline to week 16
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baseline to week 16
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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
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baseline to week 16
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Collaborators and Investigators
Sponsor
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 and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AB-IVD-MINOXIDIL-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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