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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neurogenic inflammation-QOL
Timeframe: Change from Baseline to 14 weeks
2
Neurogenic inflammation-Short Form (36) Health Survey
. 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
. 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)