search
Back to results

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

Primary Purpose

Hypotrichosis

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Latanoprost and Minoxidil
Sponsored by
Aneira Pharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypotrichosis focused on measuring Eyebrow

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • WellMaxRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Topical Latanoprost/Minoxidil formulation

Control Group

Arm Description

8 participants: Topical Latanoprost/Minoxidil formulation applied to both eyebrows once a day for 90 days

4 participants: Vehicle applied to both eyebrows once a day for 90 days

Outcomes

Primary Outcome Measures

Target Area Hair Count
Target Area Hair Count as Determined by the Brigham Tool for Alopecia

Secondary Outcome Measures

Standardized Global Photographs
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
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.

Full Information

First Posted
March 17, 2023
Last Updated
March 17, 2023
Sponsor
Aneira Pharma, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05790941
Brief Title
Proof of Concept Study of Latanoprost/Minoxidil (ANR-001.1) Topical Formulation
Official Title
Proof of Concept of Latanoprost/Minoxidil (ANR-001.1) Topical Formulation for Eyebrows
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 11, 2023 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aneira Pharma, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotrichosis
Keywords
Eyebrow

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Masking Description
Unlabeled bottle.
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topical Latanoprost/Minoxidil formulation
Arm Type
Experimental
Arm Description
8 participants: Topical Latanoprost/Minoxidil formulation applied to both eyebrows once a day for 90 days
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
4 participants: Vehicle applied to both eyebrows once a day for 90 days
Intervention Type
Combination Product
Intervention Name(s)
Latanoprost and Minoxidil
Intervention Description
Latanoprost and Minoxidil formulation for the treatment of hypotrichosis of the eyebrows.
Primary Outcome Measure Information:
Title
Target Area Hair Count
Description
Target Area Hair Count as Determined by the Brigham Tool for Alopecia
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Standardized Global Photographs
Description
1. Standardized Global Photographs and change from baseline measurement of eyebrow hair fullness using Canfield Eyebrow Hair Image Analysis.
Time Frame
90 days
Title
Change in Total Area Hair Darkness
Description
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.
Time Frame
90 days
Other Pre-specified Outcome Measures:
Title
Subject Self Assessment
Description
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.
Time Frame
90 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Cosgrove, M.D.
Phone
760-777-7698
Email
heidi@wellmax.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Cosgrove, M.D.
Organizational Affiliation
WellMax
Official's Role
Principal Investigator
Facility Information:
Facility Name
WellMax
City
Indian Wells
State/Province
California
ZIP/Postal Code
92210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Cosgrove, M.D.
Phone
760-777-7698
Email
heidi@wellmax.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs