Minoxidil Response Testing in Females With Female Pattern Hair Loss

Minoxidil Response Testing in Females With Female Pattern Hair Loss

Sponsors

Lead Sponsor: Applied Biology, Inc.

Source Applied Biology, Inc.
Brief Summary

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

Detailed 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.

Overall Status Completed
Start Date 2014-07-01
Completion Date 2018-10-01
Primary Completion Date 2018-10-01
Study Type Observational
Primary Outcome
Measure Time Frame
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count baseline to week 24
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings baseline to week 24
Secondary Outcome
Measure Time Frame
Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the change in Target Area Hair Count 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 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 baseline to week 24
Mean change in minoxidil sulfotransferase activity in plucked hairs as measured by the minoxidil response in-vitro diagnostic kit baseline to week 24
Enrollment 300
Condition
Intervention

Intervention Type: Drug

Intervention Name: 5% minoxidil topical foam

Description: 5% minoxidil topical foam

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility:
Physicians Hair Institute | Tucson, Arizona, 85719, United States
Tennessee Clinical Research Center | Nashville, Tennessee, 37215, United States
Sinclair Dermatology | East Melbourne, 3002, Australia
LTM Medical College & Hospital | Mumbai, 400022, India
Istituto Medico Tricologico/Studi Life Cronos | Florence, 50127, Italy
Location Countries

Australia

India

Italy

United States

Verification Date

2018-10-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: 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.

Label: 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.

Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

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