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

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

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

Study Overview

• Status: Recruiting
• Conditions: Hypotrichosis
• Intervention / Treatment: Combination product: Latanoprost and Minoxidil

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 Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Dan Cosgrove, M.D.; Phone Number: 760-777-7698; Email: heidi@wellmax.com

Study Locations

• United States
  • California
    • Indian Wells, California, United States, 92210
      • Recruiting
      • WellMax
      • Contact: Dan Cosgrove, M.D.; Phone Number: 760-777-7698; Email: heidi@wellmax.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical Latanoprost/Minoxidil formulation; 8 participants: Topical Latanoprost/Minoxidil formulation applied to both eyebrows once a day for 90 days	Combination product: Latanoprost and Minoxidil; Latanoprost and Minoxidil formulation for the treatment of hypotrichosis of the eyebrows.
Placebo Comparator: Control Group; 4 participants: Vehicle applied to both eyebrows once a day for 90 days	Combination product: Latanoprost and Minoxidil; Latanoprost and Minoxidil formulation for the treatment of hypotrichosis of the eyebrows.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Area Hair Count	Target Area Hair Count as Determined by the Brigham Tool for Alopecia	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized Global Photographs	1. Standardized Global Photographs and change from baseline measurement of eyebrow hair fullness using Canfield Eyebrow Hair Image Analysis.	90 days
Change in Total Area Hair Darkness	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.	90 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Self Assessment	1. Subject Self-Assessment and Investigator Global Assessment using a Canfield side-by-side comparison tool on Day 90. Measure participant's satisfaction with eyebrow treatment.	90 Days

Collaborators and Investigators

• Sponsor: Aneira Pharma, Inc.
• Investigators: Principal Investigator: Dan Cosgrove, M.D., WellMax

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2023
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: March 17, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Eyebrow
• Additional Relevant MeSH Terms: Skin Diseases; Hair Diseases; Hypotrichosis; Antihypertensive Agents; Vasodilator Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost; Minoxidil
• Other Study ID Numbers: ANR C001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No