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

Aneira Pharma

Status and phase: Enrolling; Early Phase 1

Conditions: Hypotrichosis

Treatments: Combination Product: Latanoprost and Minoxidil

Study type: Interventional

Funder types: Industry

Identifiers

NCT05790941

ANR C001

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 22 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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12 participants in 2 patient groups, including a placebo group

Topical Latanoprost/Minoxidil formulation

Experimental group

Description:

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

Treatment:

Combination Product: Latanoprost and Minoxidil

Control Group

Placebo Comparator group

Description:

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

Treatment:

Combination Product: Latanoprost and Minoxidil