Trial · NCT04409041
Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia
NCT04409041, Phase 2, Completed, Washington University School of Medicine; results first posted 2021-12-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia. Trials, record NCT04409041. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04409041
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Low-Dose Naltrexone for Lichen Planopilaris and Frontal Fibrosing Alopecia
- NCT number
- NCT04409041
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 43 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Lichen Planopilaris, Frontal Fibrosing Alopecia
- Interventions
- Low-Dose Naltrexone
- First posted
- 2020-06-01
- Last updated
- 2021-12-30
- Results first posted
- 2021-12-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Patient-Reported Itch | 12 months | Per protocol group | units on a scale | MEAN |
| PRIMARY | Change in Investigator Rated Erythema | 12 months | Per protocol group | units on a scale | MEAN |
| PRIMARY | Patient Reported Burning/Pain | 12 months | Per protocol group | units on a scale | MEAN |
| PRIMARY | Change in Investigator Rated Scale | 12 months | Per protocol group | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Patient-Reported Itch | Treatment Group (Low-dose Naltrexone) | -0.33 | 95% Confidence Interval -1.08 to 0.41 | units on a scale | |
| Change in Investigator Rated Erythema | Treatment Group (Low-dose Naltrexone) | -0.93 | 95% Confidence Interval -1.32 to -0.53 | units on a scale | |
| Patient Reported Burning/Pain | Low-dose Naltrexone Group | -0.50 | 95% Confidence Interval -1.02 to 0.02 | units on a scale | |
| Change in Investigator Rated Scale | Low-dose Naltrexone Group | -0.33 | 95% Confidence Interval -0.72 to 0.07 | units on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Group (Low-dose Naltrexone) | 43 | |
| Overall Study | COMPLETED | Treatment Group (Low-dose Naltrexone) | 26 | |
| Overall Study | NOT COMPLETED | Treatment Group (Low-dose Naltrexone) | 17 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | vivid dreams | Nervous system disorders | Treatment Group (Low-dose Naltrexone) | 7 | 34 | 7 |
| other | headache | Nervous system disorders | Treatment Group (Low-dose Naltrexone) | 3 | 34 | 3 |
| serious | Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Treatment Group (Low-dose Naltrexone) | 2 | 34 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Group (Low-dose Naltrexone) | 0 | 34 |
| Total, other adverse events | Treatment Group (Low-dose Naltrexone) | 10 | 34 |
| Total, serious adverse events | Treatment Group (Low-dose Naltrexone) | 2 | 34 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04409041
GET https://conductscience.org/api/trials/v1/NCT04409041/registered