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

NCT05790941 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: ANR C001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypotrichosis

Keywords

Eyebrow

Outcome Measures

Primary Outcomes (1)

• Target Area Hair Count

  Target Area Hair Count as Determined by the Brigham Tool for Alopecia

  90 days

Secondary Outcomes (2)

• Standardized Global Photographs

  90 days

• Change in Total Area Hair Darkness

  90 days

Other Outcomes (1)

• Subject Self Assessment

  90 Days

Study Arms (2)

Topical Latanoprost/Minoxidil formulation

EXPERIMENTAL

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

Combination Product: Latanoprost and Minoxidil

Control Group

PLACEBO COMPARATOR

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

Combination Product: Latanoprost and Minoxidil

Interventions

Latanoprost and Minoxidil COMBINATION_PRODUCT

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

Control Group; Topical Latanoprost/Minoxidil formulation

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aneira Pharma, Inc.: lead

Study Sites (1)

WellMax

Indian Wells, California, 92210, United States

RECRUITING

MeSH Terms

Conditions

Hypotrichosis

Interventions

Latanoprost; Minoxidil

Condition Hierarchy (Ancestors)

Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Dan Cosgrove, M.D.

  WellMax

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Cosgrove, M.D.

CONTACT

760-777-7698; heidi@wellmax.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Unlabeled bottle.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 30, 2023
• Study Start: March 11, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 30, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)