CompletedNCT01907490Updated Apr 28, 2020Results posted

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

A Phase 2 interventional study of Ha44 Gel in Head Lice Infestation, sponsored by Dr. Reddy's Laboratories Limited. Completed. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2020-04-28.

Sponsored by Dr. Reddy's Laboratories Limited · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 38
Allocation: Not applicable
Ages: 6 Months to 17 Years
Sex: All

Study summary

The purpose of the study is to evaluate the safety and tolerability of a single application of Ha44 Gel 0.74% w/v for the treatment of head lice under maximal use conditions.

Secondary objective is to evaluate pharmacokinetics of Ha44 and benzyl alcohol (contained in Ha44 vehicle) under maximal use conditions.

Read the detailed description

This is an open-label safety and pharmacokinetic (PK) study involving a single application of Ha44 Gel 0.74% administered under maximal use conditions.

All participants must have an active head lice infestation (at least 3 live lice) and be 6 months to 17 years of age. The study will enroll approximately 36 pediatric subjects between the ages of 6 months and 17 years.

Pediatric PK samples will be collected at 0 (predose), 30 and 60 mins and 2 and 8 hrs time points.

More than one household member with an active lice infestation may participate in the study. Eligible subjects will be consented and screened for study eligibility on Day 0 (Visit 1). All subjects will return to the study site for three follow-up clinic visits at Days 1, 7 and 14. The maximum study duration for a subject is 16 days.

Conditions studied

Head Lice Infestation

Keywords

Topical treatment of Head Lice Infestation

In context

Lead sponsor

Dr. Reddy's Laboratories Limited is the lead sponsor of 224 studies on the registry; 2 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Months to 17 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Male or female
6 months to 17 years of age
Be in good health, as determined by medical history and physical examination
Has an active head lice infestation at screening as determined by an experienced evaluator. An active infestation is defined as the presence of at least 3 live lice.
Female subjects must be:
- Of non-childbearing potential (no history of menstrual periods, post-hysterectomy, or post-menopausal for at least 2 years) OR,
- If of childbearing potential, must have a negative urine pregnancy test prior to treatment and agree to use a highly effective method of contraception from Day 0 through the Day 14 visit. Acceptable methods of contraception include abstinence, vasectomized partner, tubal ligation, combined oral hormonal contraceptive, contraceptive injection, contraceptive patch, or IUD. If a hormonal contraception is the only method, the subject must have been on a stable dose for at least 3 months.
The parent/guardian agrees to allow serial blood samples collected from subject for PK analysis during study.
Has signed an informed consent and/or assent form (ICF).

Exclusion criteria

Exclusion Criteria:

Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results.
Has current dermatological disease or inflammation on the face, scalp, ears, neck or back, including eczema, atopic dermatitis, alopecia, psoriasis or any other chronic skin disease that, in the opinion of the Investigator, would interfere with the safety or PK evaluation.
Had a prior reaction to products containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
Has been using hormonal contraception for less than 3 months.
Is pregnant or currently nursing.
Receiving systemic or topical medication, which in the opinion of the Investigator, may interfere with the study results.
Has received an investigational agent within 30 days prior to Day 0.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 38 participants (actual)

Study arms

Experimental
1
Ha44 Gel 0.74%, topical solution, maximum feasible amount applied for 10 minutes
Drug: Ha44 Gel

Interventions

DrugHa44 Gel
Eligible subjects will be treated at the study site on Day 0 with a single application of the maximum feasible amount of Ha44 Gel, to ensure saturation of the scalp and hair.
Also known as: Benzyl Alcohol

What researchers measure

Primary outcomes

Number of the Subjects With AEs.
Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.
Time frame: 3 months

Secondary outcomes

Pk Parameters: Cmax
Maximum concentration of Ha44 (Cmax)
Time frame: 0 to 8 hours
PK Parameters: Tmax
Time to maximum concentration of Ha44 (Tmax)
Time frame: 0-8 hours
PK Parameters: AUC(0-8)
Area under the concentration-time curve of Ha44 (AUC 0-8)
Time frame: 0-8 hours

Results

Posted Feb 9, 2015

Participant flow

Participant flow — Overall Study
Milestone	Ha44 Gel 0.74% w/w
Started	38
Completed	38
Not completed	0

Outcome measures

PrimaryNumber of the Subjects With AEs.

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

Time frame:: 3 months
Reported as:: Number · participants

Number of the Subjects With AEs.
participants	Ha44 Gel 0.74% w/w
Number of the Subjects With AEs.	8

SecondaryPk Parameters: Cmax

Maximum concentration of Ha44 (Cmax)

Time frame:: 0 to 8 hours
Reported as:: Mean · ng/mL

Pk Parameters: Cmax
ng/mL	HA44 Gel 0.74%
Pk Parameters: Cmax	141.4 (16 to 397)

SecondaryPK Parameters: Tmax

Time to maximum concentration of Ha44 (Tmax)

Time frame:: 0-8 hours
Reported as:: Median · hours

PK Parameters: Tmax
hours	HA44 Gel 0.74%
PK Parameters: Tmax	0.8 (0 to 2)

SecondaryPK Parameters: AUC(0-8)

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

Time frame:: 0-8 hours
Reported as:: Mean · ng.h/mL

PK Parameters: AUC(0-8)
ng.h/mL	HA44 Gel 0.74%
PK Parameters: AUC(0-8)	447.5 (80 to 971)

Adverse events

Collected over From the time of IP application on Day 0 until Day 14. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ha44 Gel 0.74% w/w	0/38 (0%)	0/38 (0%)	2/38 (5.3%)

Most frequent other events

Most frequent other events
Event	Ha44 Gel 0.74% w/w
Dermatitis contactSkin and subcutaneous tissue disorders	2/38

Baseline characteristics

Age, Customized
Age, Customized(participants)	Ha44 Gel 0.74% w/w
6months-<12 months	8
12 months- <2 years	9
2 years - <3 years	11
3years-<18 years	10

Sex: Female, Male
Sex: Female, Male(Participants)	Ha44 Gel 0.74% w/w
Female	20
Male	18

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2013, a primary completion of Jul 2013 and a completion of Dec 2013. It does not say whether these dates are actual or estimated.

Results were first posted in Feb 2015, 1 year 7 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Jul 22, 2013
First posted: Jul 25, 2013
Start: Mar 2013
Primary completionActual: Jul 2013
CompletionActual: Dec 2013
Results first posted: Feb 9, 2015
Last update: Apr 28, 2020

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Apr 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01907490
Lead sponsor: Dr. Reddy's Laboratories Limited
Collaborators: Accelovance, Target Health Inc.
Responsible party: Sponsor
First posted: Jul 25, 2013
Start date: Mar 2013
Primary completion: Jul 2013
Completion: Dec 2013
Results posted: Feb 9, 2015
Last update: Apr 28, 2020

Study contacts

Srinivas Sidgiddi, MD

study director · Dr. Reddy's Laboratories Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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