Alopecia, Female Pattern Hair Loss
Conditions
Keywords
Alopecia, Androgenetic Alopecia, Female Pattern Hair Loss, Hair Loss, Minoxidil, Hair Thinning
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.
Interventions
5% minoxidil topical foam
Sponsors
Applied Biology, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Number of hairs measured in the target area by macrophotography. |
| Sensitivity and specificity of the minoxidil response in-vitro diagnostic kit to predict at baseline the subjects ratings | baseline to week 24 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Number of hairs measured in the target area by macrophotography. |
| 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 | — |
Countries
Australia, India, Italy, United States
Outcome results
None listed