Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia

Early Phase 1

Completed

• Conditions: Lichen Planopilaris; Central Centrifugal Scarring Alopecia; Scarring Alopecia; Frontal Fibrosing Alopecia; Central Centrifugal Cicatricial Alopecia
• Interventions: Drug: Topical gabapentin

• Registration Number: NCT03346668
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study Start: 2016-01-28
• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Primary Completion: 2021-10-11
• Study Completion: 2021-10-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topical gabapentin	Topical gabapentin	gabapentin 6% solution, 1mL applied twice daily for 12 weeks

Primary Outcome Measures

Name	Time	Method
Neurogenic inflammation-QOL	Change from Baseline to 14 weeks	Complete a QOL (Quality of Life) survey Scale= (Not relevant to Extremely Relevant)
Neurogenic inflammation-Short Form (36) Health Survey	Change from Baseline to 14 weeks	Complete Short Form (36) Health Survey Scale Scale=1-5 1 being the best and 5 being the worse
Neurogenic inflammation- Visual Analog pain Scale	Change from Baseline to 14 weeks	Visual Analog Pain scale Scale = 1-10 1 being the least pain and 10 being the worse pain

Secondary Outcome Measures

Name	Time	Method
Safety and efficacy of topical 6% gabapentin -Medication side Effects	Change from Baseline to 12 weeks	Subjects will have Medication side effects collected at day 0 and ending week 12
Safety and efficacy of topical 6% gabapentin -Blood levels	Change from Baseline to 12 weeks	Subjects will have blood levels measured at Day 0 and 12 weeks
Safety and efficacy of topical 6% gabapentin -Adverse Events	Change from Baseline to 12 weeks	Subjects will have adverse events collected on day 0 and 12 weeks

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States