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

Primary Purpose

Scarring Alopecia, Frontal Fibrosing Alopecia, Lichen Planopilaris

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Topical gabapentin

About this trial

This is an interventional treatment trial for Scarring Alopecia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female adults, greater than 18 years of age
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
At least one persistent scalp symptom associated with inflammation: pain, burning, itch, tingling/crawling, stinging, or tenderness
Able to complete survey and questionnaire subjectively
Consents to participate in neurometer study and scalp biopsy acquisition
Willingness to adhere to study protocol
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:

Allergy or intolerance to gabapentin or the substances used in its compounding
Underlying disease that might be adversely affected by topical gabapentin
Application of topical immunomodulatory or immunosuppressive agent to the scalp in the preceding 2 weeks
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
Clinical evidence of secondary skin infection
Individuals who have undergone scalp reduction surgery or hair transplantation
Asymptomatic disease
Immunosuppression due to disease state or use of systemic/topical biological agents (HIV, chemotherapy, immunomodulators, history of transplantation)
Any Investigational medications within the past 30 days, including those for migraines or scarring alopecias (anti-CGRP agents)
Use of GABAergic medications (including gabapentin and pregabalin) in the preceding 2 months
Use of illicit drugs or opioid medications
Evidence of anemia, thyroid disease, sarcoidosis or other medical condition that could impact hair growth and adversely impact the outcome of the study
Implantable Cardioverter Defibrillator (ICD) or pacemaker
Subject has any medical condition that, in the judgment of the Investigator, would jeopardize the subject's safety following exposure to the administered medications

Sites / Locations

University of Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Topical gabapentin

Arm Description

gabapentin 6% solution, 1mL applied twice daily for 12 weeks

Outcomes

Primary Outcome Measures

Neurogenic inflammation-QOL

Complete a QOL (Quality of Life) survey Scale= (Not relevant to Extremely Relevant)

Neurogenic inflammation-Short Form (36) Health Survey

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

Visual Analog Pain scale Scale = 1-10 1 being the least pain and 10 being the worse pain

Secondary Outcome Measures

Safety and efficacy of topical 6% gabapentin -Medication side Effects

Subjects will have Medication side effects collected at day 0 and ending week 12

Safety and efficacy of topical 6% gabapentin -Blood levels

Subjects will have blood levels measured at Day 0 and 12 weeks

Safety and efficacy of topical 6% gabapentin -Adverse Events

Subjects will have adverse events collected on day 0 and 12 weeks

Full Information

NCT ID

NCT03346668

First Posted

September 8, 2017

Last Updated

February 9, 2022

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT03346668

Brief Title

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

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

January 28, 2016 (Actual)

Primary Completion Date

October 11, 2021 (Actual)

Study Completion Date

October 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Scarring Alopecia, Frontal Fibrosing Alopecia, Lichen Planopilaris, Central Centrifugal Cicatricial Alopecia, Central Centrifugal Scarring Alopecia

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Model Description

Cohort study

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Topical gabapentin

Arm Type

Experimental

Arm Description

gabapentin 6% solution, 1mL applied twice daily for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Topical gabapentin

Other Intervention Name(s)

gabapentin 6% solution

Intervention Description

topical gabapentin 6% solution

Primary Outcome Measure Information:

Title

Neurogenic inflammation-QOL

Description

Complete a QOL (Quality of Life) survey Scale= (Not relevant to Extremely Relevant)

Time Frame

Change from Baseline to 14 weeks

Title

Neurogenic inflammation-Short Form (36) Health Survey

Description

Complete Short Form (36) Health Survey Scale Scale=1-5 1 being the best and 5 being the worse

Time Frame

Change from Baseline to 14 weeks

Title

Neurogenic inflammation- Visual Analog pain Scale

Description

Visual Analog Pain scale Scale = 1-10 1 being the least pain and 10 being the worse pain

Time Frame

Change from Baseline to 14 weeks

Secondary Outcome Measure Information:

Title

Safety and efficacy of topical 6% gabapentin -Medication side Effects

Description

Subjects will have Medication side effects collected at day 0 and ending week 12

Time Frame

Change from Baseline to 12 weeks

Title

Safety and efficacy of topical 6% gabapentin -Blood levels

Description

Subjects will have blood levels measured at Day 0 and 12 weeks

Time Frame

Change from Baseline to 12 weeks

Title

Safety and efficacy of topical 6% gabapentin -Adverse Events

Description

Subjects will have adverse events collected on day 0 and 12 weeks

Time Frame

Change from Baseline to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female adults, greater than 18 years of age 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 At least one persistent scalp symptom associated with inflammation: pain, burning, itch, tingling/crawling, stinging, or tenderness Able to complete survey and questionnaire subjectively Consents to participate in neurometer study and scalp biopsy acquisition Willingness to adhere to study protocol 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: Allergy or intolerance to gabapentin or the substances used in its compounding Underlying disease that might be adversely affected by topical gabapentin Application of topical immunomodulatory or immunosuppressive agent to the scalp in the preceding 2 weeks 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 Clinical evidence of secondary skin infection Individuals who have undergone scalp reduction surgery or hair transplantation Asymptomatic disease Immunosuppression due to disease state or use of systemic/topical biological agents (HIV, chemotherapy, immunomodulators, history of transplantation) Any Investigational medications within the past 30 days, including those for migraines or scarring alopecias (anti-CGRP agents) Use of GABAergic medications (including gabapentin and pregabalin) in the preceding 2 months Use of illicit drugs or opioid medications Evidence of anemia, thyroid disease, sarcoidosis or other medical condition that could impact hair growth and adversely impact the outcome of the study Implantable Cardioverter Defibrillator (ICD) or pacemaker Subject has any medical condition that, in the judgment of the Investigator, would jeopardize the subject's safety following exposure to the administered medications

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria K Hordinsky, MD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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