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

Launched by MAJA KOVACEVIC, MD · Jun 29, 2015

Keywords

ClinConnect Summary

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 ...

Gender

FEMALE

Eligibility criteria

• 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