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

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.

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