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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02097485




Registration number
NCT02097485
Ethics application status
Date submitted
24/03/2014
Date registered
27/03/2014
Date last updated
11/05/2021

Titles & IDs
Public title
Ovicidal Efficacy and Safety of Abametapir Lotion 0.74% Administered for the Treatment of Head Lice Infestation
Scientific title
A Randomised, Double-Blind, Vehicle-Controlled Study of Ovicidal Efficacy and Safety of Abametapir 0.74% Administered for the Treatment of Head Lice Infestation
Secondary ID [1] 0 0
Ha03-008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head Lice Infestation 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abametapir Lotion 0.74% w/w
Treatment: Drugs - Vehicle Lotion

Active Comparator: Abametapir Lotion 0.74% w/w - Topically administered to hair and scalp for 10 minutes application.

Placebo Comparator: Vehicle Lotion - Administered to scalp and hair for 10 minutes application.


Treatment: Drugs: Abametapir Lotion 0.74% w/w
200mL abametapir lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.

Treatment: Drugs: Vehicle Lotion
control to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Hatched Eggs Pre Treatment Relative to Post Treatment
Timepoint [1] 0 0
14 days

Eligibility
Key inclusion criteria
1. Healthy male or female based on medical history

2. Six months of age or older.

3. Has an active head lice infestation with a minimum of 3 live head lice and at least 10
undamaged and unhatched head lice eggs in their hair.

4. Agrees to an examination for head lice and compliance with the study procedures.

5. All adult subjects must sign a written voluntary informed consent. For minors, the
parent/ legal guardian agrees to the subject participating in the study as determined
by the signing of an assent of informed consent.
Minimum age
6 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has scalp disease or a history of allergies or prior reactions to any head lice
products.

2. Has a condition that, in the opinion of the Investigator, may interfere with the
study.

3. Is receiving systemic or topical medication, which in the opinion of the Investigator,
may compromise the integrity of the safety and/or efficacy assessments.

4. Had treatment (over-the-counter (OTC) or home remedy medication) for head lice within
14 days prior to Day 0.

5. Has received an investigational agent within 30 days prior to Day 0.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
National Head Lice Treatment Centre - Ringwood East
Recruitment postcode(s) [1] 0 0
3135 - Ringwood East

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Dr. Reddy's Laboratories Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study was to evaluate ovicidal efficacy of a single application of
abametapir lotion 0.74% w/w intended for the treatment of head lice.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02097485
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Scott Arnold, MBBS
Address 0 0
National Head Lice Treatment Centre, Ringwood East, Victoria, Australia, 3135
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02097485