Trial Outcomes & Findings for An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation (NCT NCT01336647)

NCT ID: NCT01336647

Last Updated: 2020-04-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 142 participants
• Primary outcome timeframe: Follow up visit at days 1, 7 and 14 days
• Results posted on: 2020-04-29

Participant Flow

Participant milestones

Measure	Low Dose Ha 44 Gel Low-Dose Ha44 Gel 0.37%, it was administered topically for 10 minutes as a single dose.	High-Dose Ha44 High-Dose Ha44 Gel 0.74% it was administered topically for 10 minutes as a single dose	Vehicle Vehicle Ha44 Gel with no active incident it was administered topically for 10 minutes as a single dose.
Overall Study STARTED	46	49	47
Overall Study COMPLETED	42	48	44
Overall Study NOT COMPLETED	4	1	3

Reasons for withdrawal

Measure	Low Dose Ha 44 Gel Low-Dose Ha44 Gel 0.37%, it was administered topically for 10 minutes as a single dose.	High-Dose Ha44 High-Dose Ha44 Gel 0.74% it was administered topically for 10 minutes as a single dose	Vehicle Vehicle Ha44 Gel with no active incident it was administered topically for 10 minutes as a single dose.
Overall Study Lost to Follow-up	4	1	3

Baseline Characteristics

An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation

Baseline characteristics by cohort

Measure	Low Dose Ha44 Gel n=46 Participants Low-Dose Ha44 0.37% Gel, topically administered to hair and scalp for 10 minutes	High-Dose Ha44 n=49 Participants High-Dose Ha44 0.74% Gel, topically administered to hair and scalp for 10 minutes	Vehicle n=47 Participants Vehicle Gel without active ingredient of Ha44.	Total n=142 Participants Total of all reporting groups
Age, Categorical <=18 years	38 Participants n=5 Participants	35 Participants n=7 Participants	30 Participants n=5 Participants	103 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	14 Participants n=7 Participants	17 Participants n=5 Participants	39 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
Age, Customized	13.7 years STANDARD_DEVIATION 10.5 • n=5 Participants	15.3 years STANDARD_DEVIATION 11.3 • n=7 Participants	17.3 years STANDARD_DEVIATION 13.3 • n=5 Participants	15.4 years STANDARD_DEVIATION 11.7 • n=4 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	42 Participants n=7 Participants	44 Participants n=5 Participants	128 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants

PRIMARY outcome

Timeframe: Follow up visit at days 1, 7 and 14 days

Population: Intent to Treat

Outcome measures

Measure	Low Dose Ha44 n=46 Participants Ha44 0.37% Gel administered topically to hair and scalp for 10 minutes.	Hig Dose Ha44 n=49 Participants Ha44 0.74% Gel administered topically to hair and scalp for 10 minutes.	Vehicle n=47 Participants Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit	31 participants	42 participants	11 participants

SECONDARY outcome

Timeframe: From treatment to last visit of the study at 14 days

Population: All subjects who participated

The number of subjects with Treatment emergent AEs (TEAEs) related to the study medication will be reported by treatment group.

Outcome measures

Measure	Low Dose Ha44 n=46 Participants Ha44 0.37% Gel administered topically to hair and scalp for 10 minutes.	Hig Dose Ha44 n=49 Participants Ha44 0.74% Gel administered topically to hair and scalp for 10 minutes.	Vehicle n=47 Participants Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
Safety and Tolerability of Ha44 Gel	5 participants with treatment related AEs	8 participants with treatment related AEs	13 participants with treatment related AEs

Adverse Events

Low Dose Ha44 Gel

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

High Dose Ha44 Gel

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Vehicle

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Low Dose Ha44 Gel n=46 participants at risk Low-Dose Ha44 0.37% Gel, administered topically to hair and scalp for 10 minutes.	High Dose Ha44 Gel n=49 participants at risk High-Dose Ha44 0.74% Gel, administered topically to hair and scalp for 10 minutes.	Vehicle n=47 participants at risk Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
Skin and subcutaneous tissue disorders pruritus	17.4% 8/46 • Number of events 8 • 14 days	4.1% 2/49 • Number of events 2 • 14 days	38.3% 18/47 • Number of events 18 • 14 days
Skin and subcutaneous tissue disorders Erythema	6.5% 3/46 • Number of events 3 • 14 days	0.00% 0/49 • 14 days	4.3% 2/47 • Number of events 2 • 14 days

Additional Information

Clinical Manager

Hatchtech Pty Ltd

Phone: +61 3 9092 0490

Email: tahveninen@hatchtech.com.au

Results disclosure agreements

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

Restriction type: LTE60