Trials / Completed
CompletedNCT02624843
Bioequivalence Study for Benzyl Alcohol Lotion 5%.
Bioequivalence Study for Benzyl Alcohol Lotion 5% (Hi-Tech Pharmacal Co. LTD) and Ulesfia (Benzyl Alcohol Lotion 5%) (Shionogi Inc.) in the Treatment of Head Lice and Their Ova.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 239 (actual)
- Sponsor
- Akorn, Inc. · Industry
- Sex
- All
- Age
- 6 Months – 60 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Benzyl Alcohol Lotion 5% | White topical lotion |
| DRUG | Ulesfia (benzyl alcohol lotion) 5% | White topical lotion |
| DRUG | Placebo | White topical lotion |
Timeline
- Start date
- 2015-08-01
- Primary completion
- 2015-11-01
- Completion
- 2015-11-01
- First posted
- 2015-12-09
- Last updated
- 2021-01-27
- Results posted
- 2020-09-03
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02624843. Inclusion in this directory is not an endorsement.