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

Maja Kovacevic, MD

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Female Pattern Hair Loss Androgenetic Alopecia

Interventions

5% Topical Minoxidil SolutionDRUG

5% Topical Minoxidil Solution

15% Topical Minoxidil SolutionDRUG

15% Topical Minoxidil Solution

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Istituto Scienze Dermatologiche

Florence, Tuscany, Italy

Outcomes

Primary Outcomes

Target Area Hair Count

Target Area Hair Count. Number of hairs measured in the target area by macrophotography

Time frame: baseline to week 24

Subjects Ratings

Time frame: baseline to week 24

Secondary Outcomes

Target Area Hair Count

Target Area Hair Count. Number of hairs measured in the target area by macrophotography.

Time frame: baseline to week 12

Expert Panel Global Photography Assessment

Treatment efficacy evaluated by expert panel review of global photographs assessing hair regrowth

Time frame: baseline to week 24

Data from ClinicalTrials.gov

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