Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia

NCT03346668 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 110336
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study will serve as a pilot study to determine the efficacy and safety of topical gabapentin in the treatment of symptomatic scarring alopecia.

Conditions

Scarring Alopecia; Frontal Fibrosing Alopecia; Lichen Planopilaris; Central Centrifugal Cicatricial Alopecia; Central Centrifugal Scarring Alopecia

Outcome Measures

Primary Outcomes (3)

• Neurogenic inflammation-QOL

  Complete a QOL (Quality of Life) survey Scale= (Not relevant to Extremely Relevant)

  Change from Baseline to 14 weeks

• Neurogenic inflammation-Short Form (36) Health Survey

  Complete Short Form (36) Health Survey Scale Scale=1-5 1 being the best and 5 being the worse

  Change from Baseline to 14 weeks

• Neurogenic inflammation- Visual Analog pain Scale

  Visual Analog Pain scale Scale = 1-10 1 being the least pain and 10 being the worse pain

  Change from Baseline to 14 weeks

Secondary Outcomes (3)

• Safety and efficacy of topical 6% gabapentin -Medication side Effects

  Change from Baseline to 12 weeks

• Safety and efficacy of topical 6% gabapentin -Blood levels

  Change from Baseline to 12 weeks

• Safety and efficacy of topical 6% gabapentin -Adverse Events

  Change from Baseline to 12 weeks

Study Arms (1)

Topical gabapentin

EXPERIMENTAL

gabapentin 6% solution, 1mL applied twice daily for 12 weeks

Drug: Topical gabapentin

Interventions

Topical gabapentin DRUG

topical gabapentin 6% solution

Also known as: gabapentin 6% solution

Topical gabapentin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female adults, greater than 18 years of age
• Biopsy-proven diagnosis of primary scarring alopecia of lymphocytic inflammatory infiltrate type, indicated as one of the following conditions: lichen planopilaris, frontal fibrosing alopecia, or central centrifugal cicatricial alopecia
• At least one persistent scalp symptom associated with inflammation: pain, burning, itch, tingling/crawling, stinging, or tenderness
• Able to complete survey and questionnaire subjectively
• Consents to participate in neurometer study and scalp biopsy acquisition
• Willingness to adhere to study protocol
• If subject is taking a neuromodulatory medication (including capsaicin cream, tricyclic antidepressants, carbamazepine, phenytoin, topiramate, oxcarbazepine, lamotrigine, morphine, Botox, etc), he or she must be a stable dose for at least 6 months prior to study enrollment

You may not qualify if:

• Allergy or intolerance to gabapentin or the substances used in its compounding
• Underlying disease that might be adversely affected by topical gabapentin
• Application of topical immunomodulatory or immunosuppressive agent to the scalp in the preceding 2 weeks
• Systemic administration of corticosteroid or other systemic treatment (i.e., methotrexate, phototherapy) that has immunomodulatory or other immunosuppressive mechanism of action, in the preceding 8 weeks
• Clinical evidence of secondary skin infection
• Individuals who have undergone scalp reduction surgery or hair transplantation
• Asymptomatic disease
• Immunosuppression due to disease state or use of systemic/topical biological agents (HIV, chemotherapy, immunomodulators, history of transplantation)
• Any Investigational medications within the past 30 days, including those for migraines or scarring alopecias (anti-CGRP agents)
• Use of GABAergic medications (including gabapentin and pregabalin) in the preceding 2 months
• Use of illicit drugs or opioid medications
• Evidence of anemia, thyroid disease, sarcoidosis or other medical condition that could impact hair growth and adversely impact the outcome of the study
• Implantable Cardioverter Defibrillator (ICD) or pacemaker
• Subject has any medical condition that, in the judgment of the Investigator, would jeopardize the subject's safety following exposure to the administered medications

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Alopecia; Lichen Planus

Interventions

Gabapentin; Solutions

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Lichenoid Eruptions; Skin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Pharmaceutical Preparations

Study Officials

• Maria K Hordinsky, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cohort study

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: November 17, 2017
• Study Start: January 28, 2016
• Primary Completion: October 11, 2021
• Study Completion: October 11, 2021
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)