Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT03346668
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03346668
Study Brief:
Protocol Section:
NCT03346668