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

Early Phase 1

Recruiting

• Conditions: Hypotrichosis
• Interventions: Combination Product: Latanoprost and Minoxidil

• Registration Number: NCT05790941
• Lead Sponsor: Aneira Pharma, Inc.

Brief Summary

Study to Evaluate the safety and efficacy of a Latanoprost/Minoxidil formulation vs. placebo for the treatment of hypotrichosis of the eyebrows.

Detailed Description

A Single-Blind placebo controlled trial of the efficacy and safety of the treatment of hypotrichosis of the eyebrows comparing a subset of patients receiving a combination of latanoprost/minoxidil formulation as compared to placebo measured by a validated imaging system.

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-03-11
• Study First Submitted: 2023-03-17
• Study First Submitted QC: 2023-03-17
• Last Update Submitted: 2023-03-17
• Study First Posted: 2023-03-30
• Last Update Posted: 2023-03-30
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control Group	Latanoprost and Minoxidil	4 participants: Vehicle applied to both eyebrows once a day for 90 days
Topical Latanoprost/Minoxidil formulation	Latanoprost and Minoxidil	8 participants: Topical Latanoprost/Minoxidil formulation applied to both eyebrows once a day for 90 days

Primary Outcome Measures

Name	Time	Method
Target Area Hair Count	90 days	Target Area Hair Count as Determined by the Brigham Tool for Alopecia

Secondary Outcome Measures

Name	Time	Method
Standardized Global Photographs	90 days	1. Standardized Global Photographs and change from baseline measurement of eyebrow hair fullness using Canfield Eyebrow Hair Image Analysis.
Change in Total Area Hair Darkness	90 days	2. Change in Total Area Hair Darkness of non-vellus hairs as compared to baseline in target area, defined as change from baseline of non-vellus hairs measured in intensity units as determined by Canfield Eyebrow Hair Image Analysis.

Trial Locations

Locations (1)

WellMax; 🇺🇸 Indian Wells, California, United States