Clinical trial NCT05790941: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Hypotrichosis
Keywords: Eyebrow
Lead sponsor: Aneira Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2023-03-30
Enrollment: 12
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Target Area Hair Count
timeFrame: 90 days
Secondary outcomes:
measure: Standardized Global Photographs
timeFrame: 90 days
measure: Change in Total Area Hair Darkness
timeFrame: 90 days
Other outcomes:
measure: Subject Self Assessment
timeFrame: 90 Days
Locations:
city: Indian Wells
country: United States
facility: WellMax
state: California
Study officials:
affiliation: WellMax
name: Dan Cosgrove, M.D.
role: PRINCIPAL_INVESTIGATOR
References: