Trial · NCT03337490
A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice
NCT03337490, Phase 3, Completed, Mayne Pharma International Pty Ltd; results first posted 2020-09-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice. Trials, record NCT03337490. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03337490
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice
- NCT number
- NCT03337490
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 296 participants, actual
- Lead sponsor
- Mayne Pharma International Pty Ltd
- Conditions
- Head Lice
- Interventions
- Ivermectin 0.5% Topical Application Lotion, Ivermectin 0.5% Topical Application Lotion [SKLICE], Placebo 0% Lotion
- First posted
- 2017-11-09
- Last updated
- 2020-09-17
- Results first posted
- 2020-09-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Proportion of Index Subjects Who Are Lice Free at Day 15 | 15 Days | The primary endpoint is the proportion of index subjects who are lice free at Day 15 |
| Secondary | The Number of All Index Subjects Who Are Lice-free at Day 2 | 2 Days | The secondary endpoint includes the number of all index subjects who are lice-free at Day 2 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Proportion of Index Subjects Who Are Lice Free at Day 15 | 15 Days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Number of All Index Subjects Who Are Lice-free at Day 2 | 2 Days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Proportion of Index Subjects Who Are Lice Free at Day 15 | Ivermectin 0.5% Lotion | 106 | Participants | ||
| The Proportion of Index Subjects Who Are Lice Free at Day 15 | Ivermectin 0.5% Lotion [SKLICE] | 98 | Participants | ||
| The Proportion of Index Subjects Who Are Lice Free at Day 15 | Placebo 0% Lotion | 7 | Participants | ||
| The Number of All Index Subjects Who Are Lice-free at Day 2 | Ivermectin 0.5% Lotion | 112 | Participants | ||
| The Number of All Index Subjects Who Are Lice-free at Day 2 | Ivermectin 0.5% Lotion [SKLICE] | 109 | Participants | ||
| The Number of All Index Subjects Who Are Lice-free at Day 2 | Placebo 0% Lotion | 10 | Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ivermectin 0.5% Lotion | 128 | |
| Overall Study | STARTED | Ivermectin 0.5% Lotion [SKLICE] | 126 | |
| Overall Study | STARTED | Placebo 0% Lotion | 42 | |
| Overall Study | COMPLETED | Ivermectin 0.5% Lotion | 117 | |
| Overall Study | COMPLETED | Ivermectin 0.5% Lotion [SKLICE] | 112 | |
| Overall Study | COMPLETED | Placebo 0% Lotion | 7 | |
| Overall Study | NOT COMPLETED | Ivermectin 0.5% Lotion | 11 | |
| Overall Study | NOT COMPLETED | Ivermectin 0.5% Lotion [SKLICE] | 14 | |
| Overall Study | NOT COMPLETED | Placebo 0% Lotion | 35 |
Source ClinicalTrials.gov
Adverse events12
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 | Pyrexia | General disorders | Ivermectin 0.5% Lotion | 0 | 128 | |
| other | Pyrexia | General disorders | Ivermectin 0.5% Lotion [SKLICE] | 0 | 125 | |
| other | Pyrexia | General disorders | Placebo 0% Lotion | 1 | 42 | |
| other | Upper Resporitory Tract Infection | General disorders | Ivermectin 0.5% Lotion | 0 | 128 | |
| other | Upper Resporitory Tract Infection | General disorders | Ivermectin 0.5% Lotion [SKLICE] | 0 | 125 | |
| other | Upper Resporitory Tract Infection | General disorders | Placebo 0% Lotion | 1 | 42 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Ivermectin 0.5% Lotion | 0 | 128 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Ivermectin 0.5% Lotion [SKLICE] | 1 | 125 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Placebo 0% Lotion | 0 | 42 | |
| other | Influenza | Infections and infestations | Ivermectin 0.5% Lotion | 0 | 128 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ivermectin 0.5% Lotion | 0 | 128 |
| Total, all-cause mortality | Ivermectin 0.5% Lotion [SKLICE] | 0 | 125 |
| Total, all-cause mortality | Placebo 0% Lotion | 0 | 42 |
| Total, other adverse events | Ivermectin 0.5% Lotion | 0 | 128 |
| Total, other adverse events | Ivermectin 0.5% Lotion [SKLICE] | 3 | 125 |
| Total, other adverse events | Placebo 0% Lotion | 2 | 42 |
| Total, serious adverse events | Ivermectin 0.5% Lotion | 0 | 128 |
| Total, serious adverse events | Ivermectin 0.5% Lotion [SKLICE] | 0 | 125 |
| Total, serious adverse events | Placebo 0% Lotion | 0 | 42 |
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/NCT03337490
GET https://conductscience.org/api/trials/v1/NCT03337490/registered