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

110336

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

2016-01-28

2021-10-11

2021-10-11

Completed

Early phase I

5

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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Cohort study', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 5, 'type': 'ACTUAL'}}

2024-03-25