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

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

Detailed Description
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Primary scarring alopecias (PSAs) are poorly understood dermatologic disorders that result in permanent hair loss. Most of the scarring alopecias involve a painful course, with individuals reporting scalp pain, burning, itching, or tingling/crawling sensations that can ultimately impact physical and psychological health. There has been no study of topical neurogenic agents, such as gabapentin, to treat scarring alopecia. However topical gabapentin has been safely used in other conditions associated with chronic pain, burning, irritation, itch, or tingling, such as vulvodynia. This study will serve as a pilot study to determine the efficacy and safety of topical gabapentin in the treatment of symptomatic scarring alopecia. In this study, 10 subjects with symptomatic lymphocytic-type scarring alopecia will be recruited and treated with topical gabapentin. Disease burden will be evaluated before and after 12 weeks of treatment through reporting of subjective symptomatology via surveys/questionnaire, neurometer study, clinical assessment, and biopsies measuring levels of CGRP before and after treatment.

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

Conditions
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Scarring Alopecia, Frontal Fibrosing Alopecia, Lichen Planopilaris, Central Centrifugal Cicatricial Alopecia, Central Centrifugal Scarring Alopecia

Intervention / Treatment
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* Drug: Topical gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical gabapentin<br>gabapentin 6% solution, 1mL applied twice daily for 12 weeks | Drug: Topical gabapentin<br>* topical gabapentin 6% solution<br>* Other names: gabapentin 6% solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of topical 6% gabapentin -Medication side Effects | Subjects will have Medication side effects collected at day 0 and ending week 12 | Change from Baseline to 12 weeks | 
| Safety and efficacy of topical 6% gabapentin -Blood levels | Subjects will have blood levels measured at Day 0 and 12 weeks | Change from Baseline to 12 weeks | 
| Safety and efficacy of topical 6% gabapentin -Adverse Events | Subjects will have adverse events collected on day 0 and 12 weeks | Change from Baseline to 12 weeks |