Minoxidil Response Testing in Females With Female Pattern Hair Loss

Topical minoxidil is the only US FDA approved drug used for the treatment of AGA in females.
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 once daily for a period of at least
24 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.

Inclusion Criteria:

- Females in overall good health

- Age: 18 or older

- Female pattern hair loss

- 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 24 consecutive weeks

- Willing to use an adequate method of birth control (if applicable)

- Negative urine pregnancy test

Exclusion Criteria:

- Previous adverse event from topical minoxidil treatment

- History of hypotension

- Uncontrolled hypertension

- Pregnant, nursing, or planning a pregnancy during the study

- Prior hair transplant

- Uses wigs or hair weaves

- Have used minoxidil (topical or oral) anytime during the past 6 months

- Chronic scalp disorders that require medications

- Uses 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

- Enrolled in any other medical study or has been enrolled in any medical study in the
past 6 months