Minoxidil Dose Response Study in Females Identified Through IVD Testing as Non-Responders to 5% Topical Minoxidil

Maja Kovacevic, MD

Status

Withdrawn

Conditions

Female Pattern Hair Loss

Androgenetic Alopecia

Treatments

Drug: 15% Topical Minoxidil Solution

Drug: 5% Topical Minoxidil Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT02486848

FI-DRUG-MINOXIDIL-001

Details and patient eligibility

About

5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of female pattern hair loss. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population is relatively low i.e., 30-40% re-grow hair.

The primary purpose of this study is to assess if a higher dosage of topical minoxidil dosage (15%) will increase the number of responders among female subjects that have been identified through IVD testing as non-responders to 5% topical minoxidil.

Full description

Approximately, 40% of women suffer from female pattern hair loss by the age of 55. Currently, there is only one drug approved by the US FDA for the treatment of female pattern hair loss (AGA) - topical minoxidil.

5% topical minoxidil is the maximum dosage approved by the US FDA for the treatment of female AGA. While topical minoxidil exhibits a good safety profile, the efficacy in the overall population is relatively low i.e., 30-40% re-grow hair.

Minoxidil is a pro-drug. To elicit a clinical response, minoxidil must be converted to its active form minoxidil sulfate by a sulfotransferase enzyme found in hair follicles. The investigators have developed an in-vitro diagnostic test that correctly identifies, prior to initiating therapy, 95.9% of non-responders to 5% topical minoxidil. The diagnostic test analyzes the sulfotransferase enzymatic activity in hair follicles to determine if a sufficient amount of minoxidil will be converted to the active form required to induce hair growth. Subjects with low enzymatic activity experience little or no therapeutic benefit and a reduced frequency of adverse events.

Consequently, the investigators hypothesize that in subjects with low enzymatic activity (i.e., low minoxidil metabolizers) an increased minoxidil dosage will elicit a therapeutic response with little or no increase in the frequency of adverse events. It is thus the primary purpose of this study to assess if a higher dosage of topical minoxidil dosage (15%) will increase the number of responders among female subjects that have been identified through IVD testing as non-responders to 5% topical minoxidil.

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Females in overall good health
Age: 18 to 55
Female pattern hair loss (Sinclair 2-4)
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
Non-responder to 5% minoxidil as determined by the MX-IVD test i.e., low minoxidil metabolizer
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
Use of any hypertensive drugs
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 30 days
Responder to 5% minoxidil as determined by the MX-IVD test