Trial · NCT02624843
Bioequivalence Study for Benzyl Alcohol Lotion 5%.
NCT02624843, Phase 3, Completed, Akorn, Inc.; results first posted 2020-09-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bioequivalence Study for Benzyl Alcohol Lotion 5%. Trials, record NCT02624843. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02624843
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bioequivalence Study for Benzyl Alcohol Lotion 5%.
- NCT number
- NCT02624843
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 239 participants, actual
- Lead sponsor
- Akorn, Inc.
- Conditions
- Head Lice
- Interventions
- Benzyl Alcohol Lotion 5%, Ulesfia (benzyl alcohol lotion) 5%, Placebo
- First posted
- 2015-12-09
- Last updated
- 2021-01-27
- Results first posted
- 2020-09-03
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Infestation Successfully Eliminated by Active Treatment. | Study Day 22 +/-2 | Successful elimination of infestation by active treatment \[Time frame: 22 + 2 days\]. No evidence of active head lice infestation 22 days after enrollment. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Infestation Successfully Eliminated by Active Treatment. | Study Day 22 +/-2 | PP | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Infestation Successfully Eliminated by Active Treatment. | Benzyl Alcohol Lotion 5% | 59 | Participants | ||
| Number of Participants With Infestation Successfully Eliminated by Active Treatment. | Ulesfia (Benzyl Alcohol Lotion 5%) | 57 | Participants | ||
| Number of Participants With Infestation Successfully Eliminated by Active Treatment. | Vehicle Placebo Lotion 0% | 6 | 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 | Benzyl Alcohol Lotion 5% | 107 | |
| Overall Study | STARTED | Ulesfia (Benzyl Alcohol Lotion 5%) | 108 | |
| Overall Study | STARTED | Vehicle Placebo Lotion 0% | 24 | |
| Overall Study | COMPLETED | Benzyl Alcohol Lotion 5% | 70 | |
| Overall Study | COMPLETED | Ulesfia (Benzyl Alcohol Lotion 5%) | 72 | |
| Overall Study | COMPLETED | Vehicle Placebo Lotion 0% | 16 | |
| Overall Study | NOT COMPLETED | Benzyl Alcohol Lotion 5% | 37 | |
| Overall Study | NOT COMPLETED | Ulesfia (Benzyl Alcohol Lotion 5%) | 36 | |
| Overall Study | NOT COMPLETED | Vehicle Placebo Lotion 0% | 8 |
Source ClinicalTrials.gov
Adverse events9
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 | Skin, nervous system and general disorder | Skin and subcutaneous tissue disorders | Benzyl Alcohol Lotion 5% | 1 | 107 | 1 |
| other | Skin, nervous system and general disorder | Skin and subcutaneous tissue disorders | Ulesfia (Benzyl Alcohol Lotion 5%) | 0 | 108 | 0 |
| other | Skin, nervous system and general disorder | Skin and subcutaneous tissue disorders | Vehicle Placebo Lotion 0% | 0 | 24 | 0 |
| other | redness of eye | Eye disorders | Benzyl Alcohol Lotion 5% | 1 | 107 | 1 |
| other | redness of eye | Eye disorders | Ulesfia (Benzyl Alcohol Lotion 5%) | 0 | 108 | 0 |
| other | redness of eye | Eye disorders | Vehicle Placebo Lotion 0% | 0 | 24 | 0 |
| other | fever | General disorders | Benzyl Alcohol Lotion 5% | 0 | 107 | 0 |
| other | fever | General disorders | Ulesfia (Benzyl Alcohol Lotion 5%) | 1 | 108 | 1 |
| other | fever | General disorders | Vehicle Placebo Lotion 0% | 0 | 24 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benzyl Alcohol Lotion 5% | 0 | 107 |
| Total, all-cause mortality | Ulesfia (Benzyl Alcohol Lotion 5%) | 0 | 108 |
| Total, all-cause mortality | Vehicle Placebo Lotion 0% | 0 | 24 |
| Total, other adverse events | Benzyl Alcohol Lotion 5% | 2 | 107 |
| Total, other adverse events | Ulesfia (Benzyl Alcohol Lotion 5%) | 1 | 108 |
| Total, other adverse events | Vehicle Placebo Lotion 0% | 0 | 24 |
| Total, serious adverse events | Benzyl Alcohol Lotion 5% | 0 | 107 |
| Total, serious adverse events | Ulesfia (Benzyl Alcohol Lotion 5%) | 0 | 108 |
| Total, serious adverse events | Vehicle Placebo Lotion 0% | 0 | 24 |
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/NCT02624843
GET https://conductscience.org/api/trials/v1/NCT02624843/registered