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This study will serve as a pilot study to determine the efficacy and safety of topical gabapentin in the treatment of symptomatic scarring alopecia.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical gabapentin | Experimental | gabapentin 6% solution, 1mL applied twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topical gabapentin | Drug | topical gabapentin 6% solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurogenic inflammation-QOL | Complete a QOL (Quality of Life) survey Scale= (Not relevant to Extremely Relevant) | Change from Baseline to 14 weeks |
| 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 | Change from Baseline to 14 weeks |
| Neurogenic inflammation- Visual Analog pain Scale | Visual Analog Pain scale Scale = 1-10 1 being the least pain and 10 being the worse pain | Change from Baseline to 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and efficacy of topical 6% gabapentin -Medication side Effects | Subjects will have Medication side effects collected at day 0 and ending week 12 | Change from Baseline to 12 weeks |
| Safety and efficacy of topical 6% gabapentin -Blood levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria K Hordinsky, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 28, 2016 | Sep 7, 2017 |
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Cohort study
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Subjects will have blood levels measured at Day 0 and 12 weeks
| Change from Baseline to 12 weeks |
| Safety and efficacy of topical 6% gabapentin -Adverse Events | Subjects will have adverse events collected on day 0 and 12 weeks | Change from Baseline to 12 weeks |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| D008010 | Lichen Planus |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004364 | Pharmaceutical Preparations |
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