Who is sponsoring NCT02624843?

NCT02624843 is sponsored by Akorn, Inc..

What drugs are being tested in NCT02624843?

Interventions: Benzyl Alcohol Lotion 5%, Ulesfia (benzyl alcohol lotion) 5%, Placebo.

What is the status of NCT02624843?

NCT02624843 is currently COMPLETED.

Last reviewed 2021-01-11 · How we verify

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.

NCT02624843 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Akorn, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	239
Start date	2015-08
Completion	2015-11

Conditions

Head Lice

Interventions

Benzyl Alcohol Lotion 5%
Ulesfia (benzyl alcohol lotion) 5%
Placebo

Primary outcomes

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.

Countries

United States