Trial Outcomes & Findings for Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation (NCT NCT01907490)

Results Overview

Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

38 participants

Primary outcome timeframe

3 months

Results posted on

2020-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	Ha44 Gel 0.74% w/w Ha44 Gel 0.74% w/w Open label, one arm
Overall Study STARTED	38
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ha44 Gel 0.74% w/w n=38 Participants Ha44 Gel 0.74% w/w Open label, one arm
Age, Customized 6months-<12 months	8 participants n=5 Participants
Age, Customized 12 months- <2 years	9 participants n=5 Participants
Age, Customized 2 years - <3 years	11 participants n=5 Participants
Age, Customized 3years-<18 years	10 participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: paediatric population, children between ages 6 months to \<18 years.

Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.

Outcome measures

Outcome measures
Measure	Ha44 Gel 0.74% w/w n=38 Participants Ha44 Gel 0.74% w/w Open label, one arm
Number of the Subjects With AEs.	8 participants

SECONDARY outcome

Timeframe: 0 to 8 hours

Population: Pharmacokinetic (PK) population included subjects who had sufficient concentration-time profiles for PK analyses.

Maximum concentration of Ha44 (Cmax)

Outcome measures

Outcome measures
Measure	Ha44 Gel 0.74% w/w n=28 Participants Ha44 Gel 0.74% w/w Open label, one arm
Pk Parameters: Cmax	141.4 ng/mL Interval 16.0 to 397.0

SECONDARY outcome

Timeframe: 0-8 hours

Population: PK population

Time to maximum concentration of Ha44 (Tmax)

Outcome measures

Outcome measures
Measure	Ha44 Gel 0.74% w/w n=28 Participants Ha44 Gel 0.74% w/w Open label, one arm
PK Parameters: Tmax	0.8 hours Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 0-8 hours

Population: PK Population

Area under the concentration-time curve of Ha44 (AUC 0-8)

Outcome measures

Outcome measures
Measure	Ha44 Gel 0.74% w/w n=28 Participants Ha44 Gel 0.74% w/w Open label, one arm
PK Parameters: AUC(0-8)	447.5 ng.h/mL Interval 80.0 to 971.0

Adverse Events

Ha44 Gel 0.74% w/w

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ha44 Gel 0.74% w/w n=38 participants at risk Ha44 Gel 0.74% w/w Open label, one arm
Skin and subcutaneous tissue disorders Dermatitis contact	5.3% 2/38 • From the time of IP application on Day 0 until Day 14 Adverse events were systematically collected from the time of IP administration on Day 0 until Day 14.

Additional Information

Dr. Srinivas Sidgiddi

Dr. Reddy's Laboratories Inc.

Phone: 9084585362

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee For any publication or presentation the materials will be provided to the sponsor for approval. Sponsor will be permitted of 90-120 days for a review and shall have right to request modification if the material to be published will jeopardize the intellectual property of the sponsor .
Publication restrictions are in place

Restriction type: OTHER