Proof of Concept Study of Latanoprost/Minoxidil (ANR-001.1) Topical Formulation

Launched by ANEIRA PHARMA, INC. · Mar 17, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment for people with hypotrichosis, which means they have thin or sparse eyebrows. The treatment being studied is a special topical formulation that combines two medications, Latanoprost and Minoxidil. Researchers want to see if this new treatment is safe and effective compared to a placebo, which is a treatment that doesn’t contain any active ingredients. The trial is currently recruiting participants aged 22 to 65 who are generally healthy and have experienced active hair loss in their eyebrows within the past year.

To be eligible for the study, participants should not have any serious medical conditions that could affect hair growth or have had certain hair treatments recently. They also need to agree to avoid other hair growth therapies and supplements during the study. Participants can expect to apply the treatment as directed and attend follow-up visits to help assess its effects. This trial aims to determine if this new formulation can help improve eyebrow hair growth for those experiencing hypotrichosis.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria: • Subjects, age 22 to 65 years, in general good health.
• • Patients with diagnosed hypotrichosis of the eyebrows.
• • Subjects with active hair loss within the last 12 months.
• • Patients willing to refrain from initiation of any new vitamins or nutritional supplements for the duration of the study.
• • Patients willing to refrain from use of any hair growth therapies (oral or topical) other than the investigational product.
• • Exclusion Criteria: • Subjects with an active disease or infection, or chronic dermatological condition (eczema, psoriasis, infection, etc.) of the scalp that may interfere with the assessment of scalp skin health in the treated regions.
• • History of hair transplants, scalp reduction, current hair weave or tattooing in the target area, artificial hair coloring two months prior to initiation of study which makes it difficult to perform hair count assessment.
• • Subjects with hair loss for greater than 5 years, as medical therapy is unlikely to have much effect at restoring hair follicles inactive for that long of a time period.
• • Subjects with a history of chemotherapy, receiving cytotoxic agents, radiation, or laser/surgical therapy of the scalp within the past 12 months.
• • Any known or underlying medical problem that could influence hair growth such as HIV infection, connective tissue disease, a thyroid condition, inflammatory bowel disease or other medical conditions, at the discretion of the investigator.
• • Subjects with clinical diagnosis of hair loss other than hypotrichosis of the eyebrows.
• • Subjects with severe cardiovascular disease, uncontrolled or untreated hypertension, arrythmia or clinically relevant hypotension.
• • Subjects with known or suspected hypersensitivity or allergic reaction to any of the active or inactive components of the test articles.
• • Pregnant or lactating females or planning to become pregnant for the duration of the study.
• • Subjects using medications that potentially cause drug-induced hair loss (e.g., depotestosterone, haloperidol, methotrexate, methylprednisolone, prednisone, testosterone, divalproex sodium) within the last 3 months.
• • Current enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation.
• • Current or recent (2 months) history of severe diet or eating disorder.