Scarring AlopeciaEarly Phase 1NCT03346668
Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia
A Early Phase 1 study testing Topical gabapentin in people with Scarring Alopecia and Frontal Fibrosing Alopecia, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scarring Alopecia, Frontal Fibrosing Alopecia, Lichen Planopilaris
- What is being tested?
- Topical gabapentin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2016to 11 Oct 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
This study will serve as a pilot study to determine the efficacy and safety of topical gabapentin in the treatment of symptomatic scarring alopecia.
Read the 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
- Being tested
- Topical gabapentin
- Medical subject headings
- Alopecia, Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical gabapentinDrug
Also called gabapentin 6% solution
topical gabapentin 6% solution
| Study group | Role | What they receive |
|---|---|---|
| Topical gabapentin | Experimental | gabapentin 6% solution, 1mL applied twice daily for 12 weeks Receives: Drug: Topical gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurogenic inflammation-QOL
Complete a QOL (Quality of Life) survey Scale= (Not relevant to Extremely Relevant)
Measured: 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
Measured: 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
Measured: Change from Baseline to 14 weeks
Secondary outcomes (3)
Safety and efficacy of topical 6% gabapentin -Medication side Effects
Subjects will have Medication side effects collected at day 0 and ending week 12
Measured: 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
Measured: 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
Measured: Change from Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start28 Jan 2016
- Primary completion11 Oct 2021
- Study completion11 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scarring AlopeciaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort study
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria K Hordinsky, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346668
- Sponsor's protocol ID
- 110336
- Status last verified
- Mar 2024
- First submitted
- 8 Sep 2017
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Neurogenic Inflammation and Topical 6% Gabapentin Therapy in Symptomatic Scarring Alopecia
- ClinicalTrials.gov ID
- NCT03346668
- Acronym / sponsor ID
- 110336
- Conditions
- Scarring Alopecia, Frontal Fibrosing Alopecia, Lichen Planopilaris, Central Centrifugal Cicatricial Alopecia, Central Centrifugal Scarring Alopecia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 28 Jan 2016 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort study
| Arm | Type | Receives |
|---|---|---|
| Topical gabapentin | Experimental | Drug: Topical gabapentingabapentin 6% solution, 1mL applied twice daily for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical gabapentinAlso: gabapentin 6% solutiontopical gabapentin 6% solution | Drug | Topical gabapentin |
Primary outcome
Neurogenic inflammation-QOL
Time frame: Change from Baseline to 14 weeks
Complete a QOL (Quality of Life) survey Scale= (Not relevant to Extremely Relevant)
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
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
3 secondary outcomes
Safety and efficacy of topical 6% gabapentin -Medication side Effects
Time frame: Change from Baseline to 12 weeks
Safety and efficacy of topical 6% gabapentin -Blood levels
Time frame: Change from Baseline to 12 weeks
Safety and efficacy of topical 6% gabapentin -Adverse Events
Time frame: Change from Baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria K Hordinsky, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Topical gabapentin in people with Scarring Alopecia and Frontal Fibrosing Alopecia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurogenic inflammation-QOL (time frame: Change from Baseline to 14 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.