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Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia

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ClinicalTrials.gov Identifier: NCT04409041
Recruitment Status : Completed
First Posted : June 1, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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 9 months to monitor their progress.


Condition or disease Intervention/treatment Phase
Lichen Planopilaris Frontal Fibrosing Alopecia Drug: Low-Dose Naltrexone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Low-Dose Naltrexone in the Treatment of Lichen Planopilaris and Frontal Fibrosing Alopecia; an Uncontrolled Open-label Prospective Study
Actual Study Start Date : September 1, 2019
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020



Intervention Details:
  • Drug: Low-Dose Naltrexone
    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 9months to monitor their progress.


Primary Outcome Measures :
  1. Change in Patient-Reported Itch/Burn [ Time Frame: At baseline and every 3 months for total 9 months. ]
    0/10 scale for itch/burn

  2. Change in Investigator Rated Erythema/Scale [ Time Frame: At baseline and every 3 months for total 9 months. ]
    0-3 scale for erythema/scale

  3. Change in Progression of Hair Loss [ Time Frame: At baseline and every 3 months for total 9 months. ]
    measurement of hair loss (cm)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04409041


Locations
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United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63141
Sponsors and Collaborators
Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04409041    
Other Study ID Numbers: 201908021
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Lichen Planus
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Naltrexone
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents