Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pediculus Humanus Capitis (Head Lice)	Drug: ivermectin treatment conditioner Drug: Placebo, vehicle control	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Head Lice Lice Parasitic Diseases

Drug Information available for: Ivermectin

U.S. FDA Resources

Further study details as provided by Topaz Pharmaceuticals Inc:

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) [ Time Frame: Day 1 through Day 15 post-application ] [ Designated as safety issue: No ]
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) [ Time Frame: Day 1 through Day 8 post-application ] [ Designated as safety issue: No ]
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) [ Time Frame: Day 1 through Day 15 post-application ] [ Designated as safety issue: No ]
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). [ Time Frame: Day 1 up to Day 28 post-application ] [ Designated as safety issue: No ]

Enrollment:	78
Study Start Date:	March 2009
Study Completion Date:	April 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 0.15% ivermectin Participant on 0.15% ivermectin treatment conditioner	Drug: ivermectin treatment conditioner Application followed by thorough rinsing of the hair and scalp with water.
Experimental: 0.25% ivermectin Participants on 0.25% ivermectin treatment conditioner	Drug: ivermectin treatment conditioner Application followed by thorough rinsing of the hair and scalp with water.
Experimental: 0.50% ivermectin Participants on 0.50% ivermectin treatment conditioner	Drug: ivermectin treatment conditioner Application followed by thorough rinsing of the hair and scalp with water.
Placebo Comparator: Placebo participants on Placebo (Vehicle control)	Drug: Placebo, vehicle control Application followed by thorough rinsing of the hair and scalp with water.

Eligibility

Ages Eligible for Study:	6 Months and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857948

Locations

United States, Florida
Global Health Associates of Miami
Miami, Florida, United States, 33143

Sponsors and Collaborators

Topaz Pharmaceuticals Inc

Investigators

Study Director:

Medical Director

Sanofi Topaz

More Information

No publications provided by Topaz Pharmaceuticals Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Topaz Pharmaceuticals Inc
ClinicalTrials.gov Identifier:	NCT00857948 History of Changes
Other Study ID Numbers:	TOP003
Study First Received:	March 6, 2009
Results First Received:	March 1, 2012
Last Updated:	March 1, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Topaz Pharmaceuticals Inc:

head lice
Pediculus humanus capitis
ivermectin

Additional relevant MeSH terms:

Lice Infestations
Parasitic Diseases
Ectoparasitic Infestations
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases

Ivermectin
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013