A Phase 3 interventional study of Benzyl Alcohol Lotion 5% and Ulesfia (benzyl alcohol lotion) 5% in Head Lice, sponsored by Akorn, Inc.. Completed at 4 sites in United States. Open to participants aged 6 Months to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-27.
Sponsored by Akorn, Inc. · Phase 3, Interventional, and Treatment
To establish the therapeutic equivalence and safety of a generic Benzyl Alcohol Lotion 5% with Ulesfia Lotion 5% in eradication of head lice in the study subjects.
Akorn, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.
Drug: Benzyl Alcohol Lotion 5%
Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.
Drug: Ulesfia (benzyl alcohol lotion) 5%
Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.
Drug: Placebo
White topical lotion
White topical lotion
White topical lotion
Number of Participants With Infestation Successfully Eliminated by Active Treatment.
Successful elimination of infestation by active treatment \[Time frame: 22 + 2 days\]. No evidence of active head lice infestation 22 days after enrollment.
Time frame: Study Day 22 +/-2
| Milestone | Benzyl Alcohol Lotion 5% | Ulesfia (Benzyl Alcohol Lotion 5%) | Vehicle Placebo Lotion 0% |
|---|---|---|---|
| Started | 107 | 108 | 24 |
| Completed | 70 | 72 | 16 |
| Not completed | 37 | 36 | 8 |
Successful elimination of infestation by active treatment \[Time frame: 22 + 2 days\]. No evidence of active head lice infestation 22 days after enrollment.
| Participants | Benzyl Alcohol Lotion 5% | Ulesfia (Benzyl Alcohol Lotion 5%) | Vehicle Placebo Lotion 0% |
|---|---|---|---|
| Number of Participants With Infestation Successfully Eliminated by Active Treatment. | 59 | 57 | 6 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Benzyl Alcohol Lotion 5% | 0/107 (0%) | 0/107 (0%) | 2/107 (1.9%) |
| Ulesfia (Benzyl Alcohol Lotion 5%) | 0/108 (0%) | 0/108 (0%) | 1/108 (0.9%) |
| Vehicle Placebo Lotion 0% | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Event | Benzyl Alcohol Lotion 5% | Ulesfia (Benzyl Alcohol Lotion 5%) | Vehicle Placebo Lotion 0% |
|---|---|---|---|
| Skin, nervous system and general disorderSkin and subcutaneous tissue disorders | 1/107 | 0/108 | 0/24 |
| redness of eyeEye disorders | 1/107 | 0/108 | 0/24 |
| feverGeneral disorders | 0/107 | 1/108 | 0/24 |
| Age, Categorical(Participants) | Benzyl Alcohol Lotion 5% | Ulesfia (Benzyl Alcohol Lotion 5%) | Vehicle Placebo Lotion 0% | Total |
|---|---|---|---|---|
| <=18 years | 77 | 85 | 18 | 180 |
| Between 18 and 65 years | 30 | 23 | 6 | 59 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Benzyl Alcohol Lotion 5% | Ulesfia (Benzyl Alcohol Lotion 5%) | Vehicle Placebo Lotion 0% | Total |
|---|---|---|---|---|
| Female | 102 | 98 | 24 | 224 |
| Male | 5 | 10 | 0 | 15 |
| Region of Enrollment(participants) | Benzyl Alcohol Lotion 5% | Ulesfia (Benzyl Alcohol Lotion 5%) | Vehicle Placebo Lotion 0% | Total |
|---|---|---|---|---|
| United States | 107 | 108 | 24 | 239 |
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Akorn, Inc.