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

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

Study Overview

• Status: Completed
• Conditions: Frontal Fibrosing Alopecia; Central Centrifugal Cicatricial Alopecia; Scarring Alopecia; Central Centrifugal Scarring Alopecia; Lichen Planopilaris
• Intervention / Treatment: Drug: Topical gabapentin

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and female adults, greater than 18 years of age
2. 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
3. At least one persistent scalp symptom associated with inflammation: pain, burning, itch, tingling/crawling, stinging, or tenderness
4. Able to complete survey and questionnaire subjectively
5. Consents to participate in neurometer study and scalp biopsy acquisition
6. Willingness to adhere to study protocol
7. 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:

1. Allergy or intolerance to gabapentin or the substances used in its compounding
2. Underlying disease that might be adversely affected by topical gabapentin
3. Application of topical immunomodulatory or immunosuppressive agent to the scalp in the preceding 2 weeks
4. 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
5. Clinical evidence of secondary skin infection
6. Individuals who have undergone scalp reduction surgery or hair transplantation
7. Asymptomatic disease
8. Immunosuppression due to disease state or use of systemic/topical biological agents (HIV, chemotherapy, immunomodulators, history of transplantation)
9. Any Investigational medications within the past 30 days, including those for migraines or scarring alopecias (anti-CGRP agents)
10. Use of GABAergic medications (including gabapentin and pregabalin) in the preceding 2 months
11. Use of illicit drugs or opioid medications
12. Evidence of anemia, thyroid disease, sarcoidosis or other medical condition that could impact hair growth and adversely impact the outcome of the study
13. Implantable Cardioverter Defibrillator (ICD) or pacemaker
14. Subject has any medical condition that, in the judgment of the Investigator, would jeopardize the subject's safety following exposure to the administered medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Topical gabapentin; gabapentin 6% solution, 1mL applied twice daily for 12 weeks	Drug: Topical gabapentin; topical gabapentin 6% solution; Other Names: gabapentin 6% solution

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Maria K Hordinsky, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2016
• Primary Completion (Actual): October 11, 2021
• Study Completion (Actual): October 11, 2021

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Skin Diseases; Neurologic Manifestations; Pathological Conditions, Anatomical; Skin Diseases, Papulosquamous; Fibrosis; Hypotrichosis; Hair Diseases; Lichenoid Eruptions; Inflammation; Cicatrix; Alopecia; Alopecia Areata; Lichen Planus; Neurogenic Inflammation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: 110336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes