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

NCT ID: NCT03346668

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-28
• Study Completion Date: 2021-10-11

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Topical gabapentin

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

Group Type: EXPERIMENTAL

Topical gabapentin

Intervention Type: DRUG

topical gabapentin 6% solution

Interventions

Topical gabapentin

topical gabapentin 6% solution

Intervention Type: DRUG

Other Intervention Names

gabapentin 6% solution

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria K Hordinsky, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

110336

Identifier Type: -

Identifier Source: org_study_id