Minoxidil Response Testing in Females With Female Pattern Hair Loss

Applied Biology

Status: Completed

Conditions: Female Pattern Hair Loss; Alopecia

Treatments: Drug: 5% minoxidil topical foam

Study type: Observational

Funder types: Industry

Identifiers

NCT02206802

AB-IVD-MINOXIDIL-004

Details and patient eligibility

About

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

Full description

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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Predicted as non-responders

Description:

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.

Treatment:

Drug: 5% minoxidil topical foam

Predicted as responders

Description:

Patients that the minoxidil response in-vitro diagnostic kit predicted as responders. 5% minoxidil topical foam will be administered to subjects in this group.

Treatment:

Drug: 5% minoxidil topical foam