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

Last updated: March 17, 2023
Sponsor: Aneira Pharma, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Alopecia

Hair Loss

Treatment

N/A

Clinical Study ID

NCT05790941
ANR C001
  • Ages 22-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 nutritionalsupplements 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

Exclusion Criteria: • Subjects with an active disease or infection, or chronicdermatological condition (eczema, psoriasis, infection, etc.) of the scalp that mayinterfere with the assessment of scalp skin health in the treated regions.

  • History of hair transplants, scalp reduction, current hair weave or tattooing in thetarget area, artificial hair coloring two months prior to initiation of study whichmakes it difficult to perform hair count assessment.
  • Subjects with hair loss for greater than 5 years, as medical therapy is unlikely tohave much effect at restoring hair follicles inactive for that long of a time period.
  • Subjects with a history of chemotherapy, receiving cytotoxic agents, radiation, orlaser/surgical therapy of the scalp within the past 12 months.
  • Any known or underlying medical problem that could influence hair growth such as HIVinfection, connective tissue disease, a thyroid condition, inflammatory bowel diseaseor other medical conditions, at the discretion of the investigator.
  • Subjects with clinical diagnosis of hair loss other than hypotrichosis of theeyebrows.
  • 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 theactive or inactive components of the test articles.
  • Pregnant or lactating females or planning to become pregnant for the duration of thestudy.
  • 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 4weeks prior to study initiation.
  • Current or recent (2 months) history of severe diet or eating disorder.

Study Design

Total Participants: 12
Study Start date:
March 11, 2023
Estimated Completion Date:
June 30, 2023

Study 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.

Connect with a study center

  • WellMax

    Indian Wells, California 92210
    United States

    Active - Recruiting

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