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

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ClinicalTrials.gov Identifier: NCT03346668
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : February 10, 2022
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Scarring Alopecia Frontal Fibrosing Alopecia Lichen Planopilaris Central Centrifugal Cicatricial Alopecia Central Centrifugal Scarring Alopecia Drug: Topical gabapentin Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Cohort study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia
Actual Study Start Date : January 28, 2016
Actual Primary Completion Date : October 11, 2021
Actual Study Completion Date : October 11, 2021

Arm Intervention/treatment
Experimental: Topical gabapentin
gabapentin 6% solution, 1mL applied twice daily for 12 weeks
Drug: Topical gabapentin
topical gabapentin 6% solution
Other Name: gabapentin 6% solution

Primary Outcome Measures :
  1. Neurogenic inflammation-QOL [ Time Frame: Change from Baseline to 14 weeks ]
    Complete a QOL (Quality of Life) survey Scale= (Not relevant to Extremely Relevant)

  2. Neurogenic inflammation-Short Form (36) Health Survey [ Time Frame: 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

  3. Neurogenic inflammation- Visual Analog pain Scale [ Time Frame: 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 :
  1. Safety and efficacy of topical 6% gabapentin -Medication side Effects [ Time Frame: Change from Baseline to 12 weeks ]
    Subjects will have Medication side effects collected at day 0 and ending week 12

  2. Safety and efficacy of topical 6% gabapentin -Blood levels [ Time Frame: Change from Baseline to 12 weeks ]
    Subjects will have blood levels measured at Day 0 and 12 weeks

  3. Safety and efficacy of topical 6% gabapentin -Adverse Events [ Time Frame: Change from Baseline to 12 weeks ]
    Subjects will have adverse events collected on day 0 and 12 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346668

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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
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Principal Investigator: Maria K Hordinsky, MD University of Minnesota
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
Study Protocol  [PDF] January 28, 2016

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03346668    
Other Study ID Numbers: 110336
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Neurogenic Inflammation
Alopecia Areata
Pathologic Processes
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Neurologic Manifestations
Nervous System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents