Clinical trial NCT03346668: Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia
Official title: Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Scarring Alopecia
Frontal Fibrosing Alopecia
Lichen Planopilaris
Central Centrifugal Cicatricial Alopecia
Central Centrifugal Scarring Alopecia
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohort study
Primary purpose: TREATMENT

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 scalp pain, burning, itching, or tingling/crawling sensations that can ultimately impact physical and psychological health. There has been no study of topical neurogenic agents, such as gabapentin, to treat scarring alopecia. However topical gabapentin has been safely used in other conditions associated with chronic pain, burning, irritation, itch, or tingling, such as vulvodynia. This study will serve as a pilot study to determine the efficacy and safety of topical gabapentin in the treatment of symptomatic scarring alopecia. In this study, 10 subjects with symptomatic lymphocytic-type scarring alopecia will be recruited and treated with topical gabapentin. Disease burden will be evaluated before and after 12 weeks of treatment through reporting of subjective symptomatology via surveys/questionnaire, neurometer study, clinical assessment, and biopsies measuring levels of CGRP before and after treatment.

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

Primary outcomes:
measure: Neurogenic inflammation-QOL
timeFrame: Change from Baseline to 14 weeks
measure: Neurogenic inflammation-Short Form (36) Health Survey
timeFrame: Change from Baseline to 14 weeks
measure: Neurogenic inflammation- Visual Analog pain Scale
timeFrame: Change from Baseline to 14 weeks
Secondary outcomes:
measure: Safety and efficacy of topical 6% gabapentin -Medication side Effects
timeFrame: Change from Baseline to 12 weeks
measure: Safety and efficacy of topical 6% gabapentin -Blood levels
timeFrame: Change from Baseline to 12 weeks
measure: Safety and efficacy of topical 6% gabapentin -Adverse Events
timeFrame: Change from Baseline to 12 weeks
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Maria K Hordinsky, MD
role: PRINCIPAL_INVESTIGATOR
References: