Head LicePhase 3NCT02624843

Bioequivalence Study for Benzyl Alcohol Lotion 5%.

A Phase 3 study testing Benzyl Alcohol Lotion 5% and Ulesfia (benzyl alcohol lotion) 5% in people with Head Lice, run by Akorn, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 6 months to 60 yearsHealthy volunteers can take part
Conditions the study is for: Head Lice
What is being tested?: Benzyl Alcohol Lotion 5% and Ulesfia (benzyl alcohol lotion) 5%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 239 participants
Where: 4 sitesUnited States
Study dates: Aug 2015to Nov 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 60 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Healthy males or non-pregnant females aged 6 month or over with an upper age limit of 60 years.
Prospective participants upon examination are confirmed to have at least 3 live head lice (defined as lice adults or nymphs) and at least 5 viable appearance louse eggs (nits).
Prospective participants who give written informed consent or, if the participant is under 17 years of age, whose parent/guardian gives written informed consent to participate in the study.
Prospective participants who will be available for follow up visits over the 21 days following first treatment.
Prospective female participants (including female caregivers) of childbearing potential who are willing to provide a urine pregnancy test.
Prospective participants who agree not to shave their hair or use any other pediculicide, nit combing, or louse treatment method during the course of the study.

Who cannot join

Prospective participants with a known sensitivity to any of the ingredients in benzyl alcohol lotion 5% (Hi-Tech Pharmacal Inc) or Ulesfia 5% (Shionogi Inc).
Prospective participants with a known history of irritation or sensitivity to pediculicides or hair care products.
Prospective participants with a secondary bacterial infection of the scalp (eg. impetigo/pyoderma) or have a secondary or long term scalp condition that could make it difficult to evaluate the extent and severity of an infestation or that would present a problem in the evaluation of response to therapy (e.g., psoriatic lesions of the scalp, extensive seborrheic dermatitis).
Prospective participants who have been treated with other head lice products within 4 weeks prior to randomization.
Prospective participants who regularly shave their hair, have bleached their hair, used a permanent color on their hair, or their hair has been permanently straightened or waved within the previous 2 weeks.
Prospective participants who have been treated with Trimethoprim containing products within the previous 4 weeks, or who are currently taking such a course.

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Females who are pregnant, planning to become pregnant, during the course of the study period, or are currently breast feeding mothers.
Females of childbearing potential who are unwilling to use an adequate method of contraception from at least 4 weeks prior to the first application of treatment and until 4 weeks after the last application of treatment, or who are unwilling to take a urine pregnancy test.
Prospective participants who have participated in another clinical study or used an investigational new drug within 1 month before entry into this study.
Participants who have already participated in this clinical study.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Axis Clinical Trials
Los Angeles, California, 90017
Axis Clinical Trials
Los Angeles, California, 90036
South Florida Family Health and Research Centers (Lice Source Services Inc)
Miami, Florida, 33186
South Florida Family Health and Research Centers (Lice Source Services Inc)
Plantation, Florida, 33313

Other trials in United States

About this study

Official title: 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.

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: Head Lice
Being tested: Benzyl Alcohol Lotion 5%, Ulesfia (benzyl alcohol lotion) 5%, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Benzyl Alcohol Lotion 5%Drug
White topical lotion
Ulesfia (benzyl alcohol lotion) 5%Drug
White topical lotion
PlaceboDrug
White topical lotion

Study groups in NCT02624843
Study group	Role	What they receive
Benzyl Alcohol Lotion 5%	Experimental	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. Receives: Drug: Benzyl Alcohol Lotion 5%
Ulesfia (Benzyl Alcohol Lotion 5%)	Active comparator	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. Receives: Drug: Ulesfia (benzyl alcohol lotion) 5%
Vehicle Placebo Lotion 0%	Placebo comparator	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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Study Day 22 +/-2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2015Nov 2015

First posted9 Dec 2015 (estimated)
Study startAug 2015
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Head LiceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 239 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02624843
Sponsor's protocol ID: CTHP01
Status last verified: Jan 2021
First submitted: 25 Nov 2015
Last updated: 27 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).
Lice; Head Lice
Not yet recruiting
Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
Headlice
Not yet recruiting
Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.
Lice; Head Lice
Recruiting
Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo
Head Lice

All Head Lice trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT02624843
Acronym / sponsor ID: CTHP01
Conditions: Head Lice
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 239 participants (actual)
Lead sponsor: Akorn, Inc.Industry (pharma, biotech, devices)
Collaborators: South Florida Family Health and Research Centers, Axis Clinical Trials
Study start: Aug 2015
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 9 Dec 2015 (estimated)
Results: Posted 3 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Benzyl Alcohol Lotion 5%	Experimental	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.
Ulesfia (Benzyl Alcohol Lotion 5%)	Active comparator	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.
Vehicle Placebo Lotion 0%	Placebo comparator	Drug: PlaceboDay 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.

Who may qualify

Ages: 6 months to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Healthy males or non-pregnant females aged 6 month or over with an upper age limit of 60 years.
Prospective participants upon examination are confirmed to have at least 3 live head lice (defined as lice adults or nymphs) and at least 5 viable appearance louse eggs (nits).
Prospective participants who give written informed consent or, if the participant is under 17 years of age, whose parent/guardian gives written informed consent to participate in the study.
Prospective participants who will be available for follow up visits over the 21 days following first treatment.
Prospective female participants (including female caregivers) of childbearing potential who are willing to provide a urine pregnancy test.

Key exclusion criteria (10 listed)

Prospective participants with a known sensitivity to any of the ingredients in benzyl alcohol lotion 5% (Hi-Tech Pharmacal Inc) or Ulesfia 5% (Shionogi Inc).
Prospective participants with a known history of irritation or sensitivity to pediculicides or hair care products.
Prospective participants with a secondary bacterial infection of the scalp (eg. impetigo/pyoderma) or have a secondary or long term scalp condition that could make it difficult to evaluate the extent and severity of an infestation or that would present a problem in the evaluation of response to therapy (e.g., psoriatic lesions of the scalp, extensive seborrheic dermatitis).
Prospective participants who have been treated with other head lice products within 4 weeks prior to randomization.
Prospective participants who regularly shave their hair, have bleached their hair, used a permanent color on their hair, or their hair has been permanently straightened or waved within the previous 2 weeks.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Benzyl Alcohol Lotion 5%White topical lotion	Drug	Benzyl Alcohol Lotion 5%
Ulesfia (benzyl alcohol lotion) 5%White topical lotion	Drug	Ulesfia (Benzyl Alcohol Lotion 5%)
PlaceboWhite topical lotion	Drug	Vehicle Placebo Lotion 0%

Primary outcome

Number of Participants With Infestation Successfully Eliminated by Active Treatment.
Time frame: 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.

Results and safety

Results posted to the registry on 3 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Benzyl Alcohol Lotion 5%	107	70
Ulesfia (Benzyl Alcohol Lotion 5%)	108	72
Vehicle Placebo Lotion 0%	24	16

Primary outcome: Number of Participants With Infestation Successfully Eliminated by Active Treatment.

Time frame: Study Day 22 +/-2. Count of participants. Unit: Participants

Measure	Benzyl Alcohol Lotion 5% n = 70	Ulesfia (Benzyl Alcohol Lotion 5%) n = 72	Vehicle Placebo Lotion 0% n = 16
Value	59	57	6

Population analysed: PP

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Benzyl Alcohol Lotion 5%	0 of 107 (0%)	2 of 107 (1.9%)	0 of 107
Ulesfia (Benzyl Alcohol Lotion 5%)	0 of 108 (0%)	1 of 108 (0.9%)	0 of 108
Vehicle Placebo Lotion 0%	0 of 24 (0%)	0 of 24 (0%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Head Lice

Recruiting
Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).
Lice; Head Lice
Not yet recruiting
Comparative Study for the Evaluation of a New Medical Device Shampoo on the Treatment of Head Lice Infestation
Headlice
Not yet recruiting
Efficacy and Safetyof a Medical Device With a Physical Mode of Action (X92001919) Versus Paranix Anti-lice Shampoo.
Lice; Head Lice
Recruiting
Safety and Efficacy of Head-lice Treatments Elimax Green Lotion and Walgreens Lice Killing Shampoo
Head Lice

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elisabeth Rivera principal investigator

South Florida Family Health and Research Centers

Lydie Hazan, MD principal investigator

Axis Clinical Trials

Patrick Clarke, MD principal investigator

Axis Clinical Trials

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Benzyl Alcohol Lotion 5% and Ulesfia (benzyl alcohol lotion) 5% in people with Head Lice, run by Akorn, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Infestation Successfully Eliminated by Active Treatment. (time frame: Study Day 22 +/-2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02624843.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.