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

University of Minnesota (UMN)

Status and phase: Completed; Early Phase 1

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

Treatments: Drug: Topical gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT03346668

110336

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Topical gabapentin

Experimental group

Description:

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

Treatment:

Drug: Topical gabapentin