Phase 3 Alopecia Areata Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Women aged 18 or older who are in generally good health, with no history of heart or cardiovascular conditions or other significant health problems
• People diagnosed with female pattern hair loss (a visible thinning of hair in the top/centre of the scalp, rated at a certain level on a standard scale used by doctors)
• People whose hair colour provides enough contrast against their scalp to be measured using a specific hair analysis technology (confirmed at the first screening visit)
• People who have signed and dated a consent form after being fully informed about the trial
• Women who could become pregnant must have a negative blood pregnancy test at the first visit and a negative urine pregnancy test at the second visit
• Women who could become pregnant must either be permanently unable to have children, or agree to use a highly effective form of contraception (with a failure rate of less than 1% per year when used correctly) throughout the trial and for at least two weeks after the last dose — certain hormone-based contraceptives with anti-androgen properties are allowed if the person has been on a stable dose for at least six months before the second visit and plans to continue throughout the trial
• People willing to keep the same hairstyle, colour, and hair care routine for the full duration of the trial, maintaining sufficient hair length for measurements, and discussing any changes with trial staff before making them
• People willing to keep the same habits and timing around removing facial or body hair before each visit throughout the trial
• People who are able and willing to attend all scheduled visits, follow the treatment plan, complete lab tests, and fill in a daily electronic diary using their own device with internet access

Who may not be able to join:

• People with a known allergy or sensitivity to minoxidil or any ingredient in the trial products
• People who are pregnant or who plan to become pregnant during the trial
• People who are currently breastfeeding
• People with diagnosed high blood pressure (treated or untreated), blood pressure readings above a certain level at the screening visit, or any history or signs of heart disease (such as heart failure, irregular heartbeat, or reduced blood flow to the heart), or conditions that could increase the risk of heart problems
• People with certain scalp skin conditions in the area being studied at the screening visit, including moderate to severe dandruff under ongoing treatment, skin abrasions, pre-cancerous skin changes, inflammatory skin conditions, a skin or scalp infection in the past three months, a history of eczema or psoriasis on the scalp in the past six months, or any other type of hair loss condition other than female pattern hair loss (such as patchy hair loss, scarring hair loss, or stress-related hair loss) within the past three months (confirm with trial site)
• People who have ever had a hair transplant
• People who have had hair weaving or hair extensions within the six months before the second visit
• People with significantly abnormal blood test results or heart trace (ECG) findings at the screening visit, as assessed by the investigator
• People with both an abnormal creatinine level and an abnormal kidney filtration rate at the screening visit
• People with a significant medical history involving the kidneys, liver, digestive system, heart, lungs, skin, blood, hormones, or nervous system, if the investigator believes it could affect the trial
• People who have used certain scalp treatments before the second visit, including: hair growth products or minoxidil applied to the scalp in the past six months; hormone or anti-androgen treatments affecting hair growth in the past 12 weeks; certain prescription scalp creams (such as corticosteroids) in the past four weeks; certain over-the-counter or cosmetic hair products believed to affect hair growth (such as those containing saw palmetto or copper) in the past four weeks; light, laser, or microneedling treatment on the scalp in the past six months; or platelet-rich plasma (PRP) scalp treatment in the past six months
• People who have used certain medications by mouth or injection before the second visit, including specific drugs listed by the trial (such as finasteride, dutasteride, retinoids, certain blood pressure medications, certain anti-androgen drugs, minoxidil tablets, certain hormonal drugs, or high-dose biotin supplements above 5 mg in the past four weeks) — the restricted time periods vary by medication (confirm with trial site for specific medications)
• People who have had radiation to the scalp or chemotherapy at any point in their life
• People who have taken part in another clinical drug trial within 30 days, or within five half-lives of the other trial drug (whichever is longer), before the second visit
• People with a history of drug or alcohol dependency
• People who, in the investigator's opinion, are unlikely to follow the trial requirements or cannot give properly informed consent
• People with a close personal relationship to the investigator or trial staff, or who are employed by the company sponsoring the trial
• People who are in an institution by legal or regulatory order

Important: Always verify eligibility with the trial site directly before applying.