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

• Status: Withdrawn
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maja Kovacevic, MD
• Treatments: Minoxidil; Pharmaceutical Solutions

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