Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia (NCT03346668) | Clinical Trial Compass
CompletedEarly Phase 1
Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia
United States5 participantsStarted 2016-01-28
Plain-language summary
This study will serve as a pilot study to determine the efficacy and safety of topical gabapentin in the treatment of symptomatic scarring alopecia.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
Neurogenic inflammation-QOL
Timeframe: Change from Baseline to 14 weeks
2
Neurogenic inflammation-Short Form (36) Health Survey
✕. 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)