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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-11

Study Completion Date

2023-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hypotrichosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Unlabeled bottle.

Study Groups

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Topical Latanoprost/Minoxidil formulation

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

Group Type EXPERIMENTAL

Latanoprost and Minoxidil

Intervention Type COMBINATION_PRODUCT

Latanoprost and Minoxidil formulation for the treatment of hypotrichosis of the eyebrows.

Control Group

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

Group Type PLACEBO_COMPARATOR

Latanoprost and Minoxidil

Intervention Type COMBINATION_PRODUCT

Latanoprost and Minoxidil formulation for the treatment of hypotrichosis of the eyebrows.

Interventions

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Latanoprost and Minoxidil

Latanoprost and Minoxidil formulation for the treatment of hypotrichosis of the eyebrows.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes