Trial Outcomes & Findings for Bioequivalence Study for Benzyl Alcohol Lotion 5%. (NCT NCT02624843)

NCT ID: NCT02624843

Last Updated: 2021-01-27

Results Overview

Successful elimination of infestation by active treatment \[Time frame: 22 + 2 days\]. No evidence of active head lice infestation 22 days after enrollment.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 239 participants
• Primary outcome timeframe: Study Day 22 +/-2
• Results posted on: 2021-01-27

Participant Flow

Participant milestones

Measure	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. Benzyl Alcohol Lotion 5%: White topical lotion	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. Ulesfia (benzyl alcohol lotion) 5%: White topical lotion	Vehicle Placebo Lotion 0% 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. Placebo: White topical lotion
Overall Study STARTED	107	108	24
Overall Study COMPLETED	70	72	16
Overall Study NOT COMPLETED	37	36	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bioequivalence Study for Benzyl Alcohol Lotion 5%.

Baseline characteristics by cohort

Measure	Benzyl Alcohol Lotion 5% n=107 Participants 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. Benzyl Alcohol Lotion 5%: White topical lotion	Ulesfia (Benzyl Alcohol Lotion 5%) n=108 Participants 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%: White topical lotion	Vehicle Placebo Lotion 0% n=24 Participants 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. Placebo: White topical lotion	Total n=239 Participants Total of all reporting groups
Age, Categorical <=18 years	77 Participants n=5 Participants	85 Participants n=7 Participants	18 Participants n=5 Participants	180 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	23 Participants n=7 Participants	6 Participants n=5 Participants	59 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	102 Participants n=5 Participants	98 Participants n=7 Participants	24 Participants n=5 Participants	224 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	10 Participants n=7 Participants	0 Participants n=5 Participants	15 Participants n=4 Participants
Region of Enrollment United States	107 participants n=5 Participants	108 participants n=7 Participants	24 participants n=5 Participants	239 participants n=4 Participants

PRIMARY outcome

Timeframe: Study Day 22 +/-2

Population: PP

Successful elimination of infestation by active treatment [Time frame: 22 + 2 days]. No evidence of active head lice infestation 22 days after enrollment.

Outcome measures

Measure	Benzyl Alcohol Lotion 5% n=70 Participants 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. Benzyl Alcohol Lotion 5%: White topical lotion	Ulesfia (Benzyl Alcohol Lotion 5%) n=72 Participants 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%: White topical lotion	Vehicle Placebo Lotion 0% n=16 Participants 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. Placebo: White topical lotion
Number of Participants With Infestation Successfully Eliminated by Active Treatment.	59 Participants	57 Participants	6 Participants

Adverse Events

Benzyl Alcohol Lotion 5%

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Ulesfia (Benzyl Alcohol Lotion 5%)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Vehicle Placebo Lotion 0%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Benzyl Alcohol Lotion 5% n=107 participants at risk 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. Benzyl Alcohol Lotion 5%: White topical lotion	Ulesfia (Benzyl Alcohol Lotion 5%) n=108 participants at risk 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%: White topical lotion	Vehicle Placebo Lotion 0% n=24 participants at risk 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. Placebo: White topical lotion
Skin and subcutaneous tissue disorders Skin, nervous system and general disorder	0.93% 1/107 • Number of events 1	0.00% 0/108	0.00% 0/24
Eye disorders redness of eye	0.93% 1/107 • Number of events 1	0.00% 0/108	0.00% 0/24
General disorders fever	0.00% 0/107	0.93% 1/108 • Number of events 1	0.00% 0/24

Additional Information

Elisabeth Rivera

South Florida Family Health & Research

Phone: 3053870051

Email: elisabeth@sffhrc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place