Minoxidil Response Testing in Males With Androgenetic Alopecia
| Status: | Completed |
|---|---|
| Conditions: | Dermatology, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 49 |
| Updated: | 10/7/2018 |
| Start Date: | July 2014 |
| End Date: | October 2018 |
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.
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.
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
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