Minoxidil Response Testing in Females With Female Pattern Hair Loss

N/ACompletedNCT02206802

Applied Biology, Inc.300 enrolled

Overview

The primary purpose of this study is to evaluate the clinical validity of the minoxidil response in-vitro diagnostic kit.

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Alopecia Female Pattern Hair Loss

Interventions

5% minoxidil topical foamDRUG

5% minoxidil topical foam

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Physicians Hair Institute

Tucson, Arizona, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Sinclair Dermatology

East Melbourne, Australia

LTM Medical College & Hospital

Mumbai, India

Outcomes

Primary Outcomes

Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count

Number of hairs measured in the target area by macrophotography.