RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-03-11

Study Completion:2023-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05790941

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* 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.

Contacts and Locations

Study Contact

Dan Cosgrove, M.D.

CONTACT

760-777-7698

heidi@wellmax.com

Principal Investigator

Dan Cosgrove, M.D.

PRINCIPAL_INVESTIGATOR

WellMax

Study Locations (Sites)

WellMax

Indian Wells, California, 92210

United States

Collaborators and Investigators

Sponsor: Aneira Pharma, Inc.

Dan Cosgrove, M.D., PRINCIPAL_INVESTIGATOR, WellMax

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-11

Study Completion Date2023-06-30

Study Record Updates

Study Start Date2023-03-11

Study Completion Date2023-06-30

Terms related to this study

Keywords Provided by Researchers

Eyebrow

Additional Relevant MeSH Terms

Hypotrichosis