Status:
COMPLETED
Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia
Lead Sponsor:
University of Minnesota
Conditions:
Scarring Alopecia
Frontal Fibrosing Alopecia
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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.
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
- 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)
- Any Investigational medications within the past 30 days, including those for migraines or scarring alopecias (anti-CGRP agents)
- Use of GABAergic medications (including gabapentin and pregabalin) in the preceding 2 months
- Use of illicit drugs or opioid medications
- Evidence of anemia, thyroid disease, sarcoidosis or other medical condition that could impact hair growth and adversely impact the outcome of the study
- Implantable Cardioverter Defibrillator (ICD) or pacemaker
- Subject has any medical condition that, in the judgment of the Investigator, would jeopardize the subject's safety following exposure to the administered medications
Key Trial Info
Start Date :
January 28 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03346668
Start Date
January 28 2016
End Date
October 11 2021
Last Update
March 25 2024
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455