An Early Phase 1 interventional study of Topical gabapentin in Scarring Alopecia, Frontal Fibrosing Alopecia and Lichen Planopilaris, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-25.
Sponsored by University of Minnesota · Early Phase 1, Interventional, and Treatment
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.
511 studies on the registry are indexed under Alopecia; 128 are open to participants now.
This study's enrollment of 5 is below the median of 50 across 430 interventional studies indexed under Alopecia.
Browse Alopecia studies →University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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The human immunodeficiency virus, which weakens the immune system.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
gabapentin 6% solution, 1mL applied twice daily for 12 weeks
Drug: Topical gabapentin
topical gabapentin 6% solution
Also known as: gabapentin 6% solution
Neurogenic inflammation-QOL
Complete a QOL (Quality of Life) survey Scale= (Not relevant to Extremely Relevant)
Time frame: 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
Time frame: 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
Time frame: Change from Baseline to 14 weeks
Safety and efficacy of topical 6% gabapentin -Medication side Effects
Subjects will have Medication side effects collected at day 0 and ending week 12
Time frame: Change from Baseline to 12 weeks
Safety and efficacy of topical 6% gabapentin -Blood levels
Subjects will have blood levels measured at Day 0 and 12 weeks
Time frame: 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
Time frame: Change from Baseline to 12 weeks
Plan to share: No
Ran from Jan 2016 to primary completion in Oct 2021, 68 months.
Of 33 phase 1 interventional studies under Alopecia, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 57. This study's 68 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Gabapentin