Minoxidil Response Testing in Males With Androgenetic Alopecia

Applied Biology

Status: Completed

Conditions: Androgenetic Alopecia

Treatments: Drug: 5% minoxidil topical foam

Study type: Observational

Funder types: Industry

Identifiers

NCT02198261

AB-IVD-MINOXIDIL-003

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Male

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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

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