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

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

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Minnesota

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

Investigators

• 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

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03346668
• Other Study ID Numbers: 110336
• First Posted: November 17, 2017
• Last Update Posted: February 10, 2022
• Last Verified: February 2022

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:

Neurogenic Inflammation; Alopecia; Alopecia Areata; Inflammation; Cicatrix; Pathologic Processes; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical; Fibrosis; Neurologic Manifestations; Nervous System Diseases; Gabapentin; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; 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