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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 : Recruiting
First Posted : November 17, 2017
Last Update Posted : May 31, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 30, 2019


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



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

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


Contacts
Contact: Irmina Wallander, BA 612-624-5721 wall0396@umn.edu
Contact: Jane Boyer 612-626-4454 boyer009@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Irmina Wallander, RN    612-624-5721    wall0396@umn.edu   
Contact: Jane Boyer    612-626-4454    boyer009@umn.edu   
Principal Investigator: Maria Hordinsky, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Maria K Hordinsky, MD University of Minnesota - Clinical and Translational Science Institute
  Study Documents (Full-Text)

Documents provided by University of Minnesota - Clinical and Translational Science Institute:
Study Protocol  [PDF] January 28, 2016


Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03346668     History of Changes
Other Study ID Numbers: 1308M40801
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: May 31, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Alopecia
Alopecia Areata
Inflammation
Cicatrix
Neurogenic Inflammation
Pathologic Processes
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Fibrosis
Neurologic Manifestations
Nervous System Diseases
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists