Overview

This trial is active, not recruiting.

Conditions alopecia, female pattern hair loss
Treatment 5% minoxidil topical foam
Sponsor Applied Biology, Inc.
Start date July 2014
End date December 2016
Trial size 300 participants
Trial identifier NCT02206802, AB-IVD-MINOXIDIL-004

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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.
5% minoxidil topical foam Rogaine 5% minoxidil foam
5% minoxidil topical foam
Patients that the minoxidil response in-vitro diagnostic kit predicted as responders. 5% minoxidil topical foam will be administered to subjects in this group.
5% minoxidil topical foam Rogaine 5% minoxidil foam
5% minoxidil topical foam

Primary Outcomes

Measure
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count
time frame: baseline to week 24
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings
time frame: baseline to week 24

Secondary Outcomes

Measure
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count
time frame: baseline to week 12
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the treatment efficacy evaluated by expert panel review of global photographs assessing hair regrowth
time frame: baseline to week 24
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the mean change in non-vellus hair diameter in the target region
time frame: baseline to week 24
Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit
time frame: baseline to week 24

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Minoxidil Response Testing in Females With Female Pattern Hair Loss
Principal investigator Sharon Keene, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Applied Biology, Inc..