Trial Outcomes & Findings for Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia (NCT NCT04409041)

NCT ID: NCT04409041

Last Updated: 2021-12-30

Results Overview

0-10 scale for itch. Lower scores are better outcome. A change between two time points is reported at 12 months.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 43 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2021-12-30

Participant Flow

Participant milestones

Measure	Treatment Group (Low-dose Naltrexone) Everyone enrolled received low-dose naltrexone at 3mg oral daily.
Overall Study STARTED	43
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Treatment Group (Low-dose Naltrexone) n=43 Participants Everyone enrolled received low-dose naltrexone at 3mg oral daily.
Age, Continuous	65 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Per protocol group

0-10 scale for itch. Lower scores are better outcome. A change between two time points is reported at 12 months.

Outcome measures

Measure	Treatment Group (Low-dose Naltrexone) n=26 Participants Everyone enrolled received low-dose naltrexone at 3mg oral daily.
Change in Patient-Reported Itch	-0.33 units on a scale Interval -1.08 to 0.41

PRIMARY outcome

Timeframe: 12 months

Population: Per protocol group

0-3 scale for erythema. Higher scores are worse. A change between two time points is reported at 12 months.

Outcome measures

Measure	Treatment Group (Low-dose Naltrexone) n=26 Participants Everyone enrolled received low-dose naltrexone at 3mg oral daily.
Change in Investigator Rated Erythema	-0.93 units on a scale Interval -1.32 to -0.53

PRIMARY outcome

Timeframe: 12 months

Population: Per protocol group

Patient reported burning/pain on 0-10 scale. Higher values are worse. A change between two time points is reported at 12 months.

Outcome measures

Measure	Treatment Group (Low-dose Naltrexone) n=26 Participants Everyone enrolled received low-dose naltrexone at 3mg oral daily.
Patient Reported Burning/Pain	-0.50 units on a scale Interval -1.02 to 0.02

PRIMARY outcome

Timeframe: 12 months

Population: Per protocol group

Investigator assessed outcome of scale on 0-3 scale. Higher numbers are worse. A change between two time points is reported at 12 months.

Outcome measures

Measure	Treatment Group (Low-dose Naltrexone) n=26 Participants Everyone enrolled received low-dose naltrexone at 3mg oral daily.
Change in Investigator Rated Scale	-0.33 units on a scale Interval -0.72 to 0.07

Adverse Events

Treatment Group (Low-dose Naltrexone)

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment Group (Low-dose Naltrexone) n=34 participants at risk Everyone enrolled received low-dose naltrexone at 3mg oral daily.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	5.9% 2/34 • Number of events 2 • 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).

Other adverse events

Measure	Treatment Group (Low-dose Naltrexone) n=34 participants at risk Everyone enrolled received low-dose naltrexone at 3mg oral daily.
Nervous system disorders vivid dreams	20.6% 7/34 • Number of events 7 • 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).
Nervous system disorders headache	8.8% 3/34 • Number of events 3 • 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).

Additional Information

Dr. Caroline Mann

Washington University

Phone: (314) 996-8010

Email: cmann@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place