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Minoxidil Response Testing in Males With Androgenetic Alopecia
NCT02198261 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG 5% minoxidil topical foam
Study Locations (5)
Other
- Sinclair Dermatology — East Melbourne
- LTM Medical College & Hospital — Mumbai
- Istituto Medico Tricologico/Studi Life Cronos — Florence
Arizona
- Physicians Hair Institute — Tucson
Tennessee
- Tennessee Clinical Research Center — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2014-07 |
| Est. Completion | 2018-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02198261
The ClinicalTrials.gov registry entry for NCT02198261 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Applied Biology, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Androgenetic Alopecia appearing as the primary indexed condition, and to 1 intervention — of which 5% minoxidil topical foam is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02198261 reports 5 study locations spanning 3 distinct geographic areas — top geographies include Other, Arizona, Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02198261 about?
NCT02198261 is a clinical study titled "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 u...
What is the current status of trial NCT02198261?
This trial is currently completed. The enrollment target is 300 participants. The study started on 2014-07. Estimated completion is 2018-10.
What conditions does trial NCT02198261 study?
This clinical trial studies the following conditions: Androgenetic Alopecia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02198261?
The interventions under investigation include: 5% minoxidil topical foam (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02198261?
This trial is sponsored by Applied Biology, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02198261 being conducted?
This trial has 5 study locations across Arizona, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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