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Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation

Primary Purpose

Pediculus Humanus Capitis (Head Lice)

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ivermectin treatment conditioner

Placebo, vehicle control

About this trial

This is an interventional treatment trial for Pediculus Humanus Capitis (Head Lice) focused on measuring head lice, Pediculus humanus capitis, ivermectin

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects who are at least 6 months old and weighing at least 15 kg.
Infestation with head lice and viable nits.
Are otherwise in a normal state of health.
Willing and able to attend all study visits as scheduled.
Agree not to cut or chemically treat their hair in the period between treatment and the final visit.
The subject and/or his/her parent/legal guardian have provided written informed consent, and, if appropriate, the child has provided assent.
Females of childbearing potential must have a negative urine pregnancy test at screening and agree to take reasonable precautions against becoming pregnant during the study period.

Exclusion Criteria:

Subjects who have received any over the counter or prescription treatment for head lice in the last 2 weeks.
Subjects unable to comply with the study obligations and all study visits.
Subjects with eczema or other chronic conditions of the scalp and skin.
Subjects in a household with more than 5 infested members.
Subjects with a history of allergy to ivermectin or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids.
Subjects with neurologic conditions including a seizure disorder or history of seizures.
Subjects with an infestation of body lice or pubic lice (determined by questioning).
Subjects suffering from a condition likely to require medical attention, including administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment, which in the opinion of the Investigator and visiting physician could influence the results of the study.
Subjects with other diagnoses which, in the opinion of the Investigator, would interfere with efficacy or safety assessments or would preclude study participation.
Subjects with very short (shaved) hair.
Subjects who have been treated with a systemic antibiotic within the previous 2 weeks before screening.
Subjects who have been previously enrolled in any clinical study within the past 30 days; subjects may not participate in another study while participating in this study.
Pregnant and/or nursing females.

Sites / Locations

Global Health Associates of Miami

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

0.15% ivermectin

0.25% ivermectin

0.50% ivermectin

Placebo

Arm Description

Participant on 0.15% ivermectin treatment conditioner

Participants on 0.25% ivermectin treatment conditioner

Participants on 0.50% ivermectin treatment conditioner

participants on Placebo (Vehicle control)

Outcomes

Primary Outcome Measures

Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)

Live lice eradication was assessed by visual checks of hair and scalp on Days 1, 2 and 8 and by visual checks and counting both live and dead lice from rinse water on Day 15. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.

Secondary Outcome Measures

Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)

Live lice eradication was assessed on Days 1, 2, and 8 by visual checks of hair and scalp. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.

Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)

The severity of lice infestation was determined by visual checks of hair and scalp. Severity was rated as None: no live lice; Mild: 1 to 5 live lice; Moderate: 6 to 10 live lice; Severe: 11 to 20 live lice; or Very severe > 20 live lice.

Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).

Full Information

NCT ID

NCT00857948

First Posted

March 6, 2009

Last Updated

March 1, 2012

Sponsor

Topaz Pharmaceuticals Inc

1. Study Identification

Unique Protocol Identification Number

NCT00857948

Brief Title

Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation

Official Title

A Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of 3 Strengths of Ivermectin Treatment Conditioner and Placebo in Subjects With Pediculus Humanus Capitis (Head Lice) Infestation

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Topaz Pharmaceuticals Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a Phase 2 single center study designed to compare the safety, local tolerability, and efficacy of 3 strengths of ivermectin treatment conditioner to placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pediculus Humanus Capitis (Head Lice)

Keywords

head lice, Pediculus humanus capitis, ivermectin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.15% ivermectin

Arm Type

Experimental

Arm Description

Participant on 0.15% ivermectin treatment conditioner

Arm Title

0.25% ivermectin

Arm Type

Experimental

Arm Description

Participants on 0.25% ivermectin treatment conditioner

Arm Title

0.50% ivermectin

Arm Type

Experimental

Arm Description

Participants on 0.50% ivermectin treatment conditioner

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

participants on Placebo (Vehicle control)

Intervention Type

Drug

Intervention Name(s)

ivermectin treatment conditioner

Intervention Description

Application followed by thorough rinsing of the hair and scalp with water.

Intervention Type

Drug

Intervention Name(s)

Placebo, vehicle control

Intervention Description

Application followed by thorough rinsing of the hair and scalp with water.

Primary Outcome Measure Information:

Title

Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)

Description

Time Frame

Day 1 through Day 15 post-application

Secondary Outcome Measure Information:

Title

Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)

Description

Live lice eradication was assessed on Days 1, 2, and 8 by visual checks of hair and scalp. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.

Time Frame

Day 1 through Day 8 post-application

Title

Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)

Description

Time Frame

Day 1 through Day 15 post-application

Title

Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).

Time Frame

Day 1 up to Day 28 post-application

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who are at least 6 months old and weighing at least 15 kg. Infestation with head lice and viable nits. Are otherwise in a normal state of health. Willing and able to attend all study visits as scheduled. Agree not to cut or chemically treat their hair in the period between treatment and the final visit. The subject and/or his/her parent/legal guardian have provided written informed consent, and, if appropriate, the child has provided assent. Females of childbearing potential must have a negative urine pregnancy test at screening and agree to take reasonable precautions against becoming pregnant during the study period. Exclusion Criteria: Subjects who have received any over the counter or prescription treatment for head lice in the last 2 weeks. Subjects unable to comply with the study obligations and all study visits. Subjects with eczema or other chronic conditions of the scalp and skin. Subjects in a household with more than 5 infested members. Subjects with a history of allergy to ivermectin or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids. Subjects with neurologic conditions including a seizure disorder or history of seizures. Subjects with an infestation of body lice or pubic lice (determined by questioning). Subjects suffering from a condition likely to require medical attention, including administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment, which in the opinion of the Investigator and visiting physician could influence the results of the study. Subjects with other diagnoses which, in the opinion of the Investigator, would interfere with efficacy or safety assessments or would preclude study participation. Subjects with very short (shaved) hair. Subjects who have been treated with a systemic antibiotic within the previous 2 weeks before screening. Subjects who have been previously enrolled in any clinical study within the past 30 days; subjects may not participate in another study while participating in this study. Pregnant and/or nursing females.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Sanofi Topaz

Official's Role

Study Director

Facility Information:

Facility Name

Global Health Associates of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

23278618

Citation

Meinking TL, Mertz-Rivera K, Villar ME, Bell M. Assessment of the safety and efficacy of three concentrations of topical ivermectin lotion as a treatment for head lice infestation. Int J Dermatol. 2013 Jan;52(1):106-12. doi: 10.1111/j.1365-4632.2012.05629.x.

Results Reference

derived

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Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation

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