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Oral naltrexone was initially FDA approved to treat opioid use disorder and alcohol dependence at doses from 50-100mg/day. At lower doses of 1-5mg/day, naltrexone has been used off-label with success in treatment of several dermatologic conditions including the scarring hair loss disease lichen planopilaris. A recent case series of four patients with lichen planopilaris and a subtype, frontal fibrosing alopecia, treated with oral low-dose naltrexone at 3mg daily showed reduction of itch, clinical evidence of inflammation of the scalp, and of disease progression. There were no reported adverse events.
Based on the promising evidence, we propose using low-dose naltrexone at a daily dose of 3mg to treat lichen planopilaris and frontal fibrosing alopecia. The patients would be continued on their other medications for these conditions. The study would be open-label, so all participants would receive the low-dose naltrexone. Patients would be seen at 0,3,6 and 12 months to monitor their progress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-dose naltrexone group | Experimental | All participants were prescribed low-dose naltrexone at 3mg oral daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Dose Naltrexone | Drug | Based on the promising evidence, we propose using low-dose naltrexone at a daily dose of 3mg to treat lichen planopilaris and frontal fibrosing alopecia. The patients would be continued on their other medications for these conditions. The study would be open-label, so all participants would receive the low-dose naltrexone. Patients would be seen at 0,3,6 and 12 months to monitor their progress. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient-Reported Itch | 0-10 scale for itch. Lower scores are better outcome. A change between two time points is reported at 12 months. | 12 months |
| Change in Investigator Rated Erythema | 0-3 scale for erythema. Higher scores are worse. A change between two time points is reported at 12 months. | 12 months |
| Patient Reported Burning/Pain | Patient reported burning/pain on 0-10 scale. Higher values are worse. A change between two time points is reported at 12 months. | 12 months |
| Change in Investigator Rated Scale | Investigator assessed outcome of scale on 0-3 scale. Higher numbers are worse. A change between two time points is reported at 12 months. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63141 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group (Low-dose Naltrexone) | Everyone enrolled received low-dose naltrexone at 3mg oral daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
43 patients enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group (Low-dose Naltrexone) | Everyone enrolled received low-dose naltrexone at 3mg oral daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Patient-Reported Itch | 0-10 scale for itch. Lower scores are better outcome. A change between two time points is reported at 12 months. | Per protocol group | Posted | Mean | 95% Confidence Interval | units on a scale | 12 months |
|
|
12 months.
Adverse events collected for the 12-month study period. There was no control group. 34 patients received at least one dose of naltrexone and were assessed for adverse events (however only 26 patients had follow up assessments that allowed them to be included in the efficacy analysis for primary outcomes).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group (Low-dose Naltrexone) | Everyone enrolled received low-dose naltrexone at 3mg oral daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vivid dreams | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Caroline Mann | Washington University | (314) 996-8010 | cmann@wustl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2019 | Oct 21, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008010 | Lichen Planus |
| ID | Term |
|---|---|
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Primary | Change in Investigator Rated Erythema | 0-3 scale for erythema. Higher scores are worse. A change between two time points is reported at 12 months. | Per protocol group | Posted | Mean | 95% Confidence Interval | units on a scale | 12 months |
|
|
|
| Primary | Patient Reported Burning/Pain | Patient reported burning/pain on 0-10 scale. Higher values are worse. A change between two time points is reported at 12 months. | Per protocol group | Posted | Mean | 95% Confidence Interval | units on a scale | 12 months |
|
|
|
| Primary | Change in Investigator Rated Scale | Investigator assessed outcome of scale on 0-3 scale. Higher numbers are worse. A change between two time points is reported at 12 months. | Per protocol group | Posted | Mean | 95% Confidence Interval | units on a scale | 12 months |
|
|
|
| 0 |
| 34 |
| 2 |
| 34 |
| 10 |
| 34 |
| headache | Nervous system disorders | Non-systematic Assessment |
|
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| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |