Frontal Fibrosing Alopecia, Lichen Planopilaris
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults age 18 or greater * clinically or histologically confirmed diagnosis of lichen planopilaris or frontal fibrosing alopecia
Exclusion criteria
* known allergy or hypersensitivity to naltrexone * patients with concurrent use of opioids * active depression, schizophrenia, and bipolar disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-Reported Itch | 12 months | 0-10 scale for itch. Lower scores are better outcome. A change between two time points is reported at 12 months. |
| Change in Investigator Rated Erythema | 12 months | 0-3 scale for erythema. Higher scores are worse. A change between two time points is reported at 12 months. |
| Patient Reported Burning/Pain | 12 months | Patient reported burning/pain on 0-10 scale. Higher values are worse. A change between two time points is reported at 12 months. |
| Change in Investigator Rated Scale | 12 months | Investigator assessed outcome of scale on 0-3 scale. Higher numbers are worse. A change between two time points is reported at 12 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group (Low-dose Naltrexone) Everyone enrolled received low-dose naltrexone at 3mg oral daily. | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | Treatment Group (Low-dose Naltrexone) |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 41 Participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 34 |
| other Total, other adverse events | 10 / 34 |
| serious Total, serious adverse events | 2 / 34 |
Outcome results
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.
Time frame: 12 months
Population: Per protocol group
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Group (Low-dose Naltrexone) | Change in Investigator Rated Erythema | -0.93 units on a scale |
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.
Time frame: 12 months
Population: Per protocol group
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Group (Low-dose Naltrexone) | Change in Investigator Rated Scale | -0.33 units on a scale |
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.
Time frame: 12 months
Population: Per protocol group
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Group (Low-dose Naltrexone) | Change in Patient-Reported Itch | -0.33 units on a scale |
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.
Time frame: 12 months
Population: Per protocol group
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Treatment Group (Low-dose Naltrexone) | Patient Reported Burning/Pain | -0.50 units on a scale |