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

NCT00857948 | Completed Phase 2 Results

• 1 other identifier: TOP003
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediculus Humanus Capitis (Head Lice)

Keywords

head lice; Pediculus humanus capitis; ivermectin

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 through Day 15 post-application

Secondary Outcomes (3)

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

  Day 1 through Day 8 post-application

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

  Day 1 through Day 15 post-application

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

  Day 1 up to Day 28 post-application

Study Arms (4)

0.15% ivermectin

EXPERIMENTAL

Participant on 0.15% ivermectin treatment conditioner

Drug: ivermectin treatment conditioner

0.25% ivermectin

EXPERIMENTAL

Participants on 0.25% ivermectin treatment conditioner

Drug: ivermectin treatment conditioner

0.50% ivermectin

EXPERIMENTAL

Participants on 0.50% ivermectin treatment conditioner

Drug: ivermectin treatment conditioner

Placebo

PLACEBO COMPARATOR

participants on Placebo (Vehicle control)

Drug: Placebo, vehicle control

Interventions

ivermectin treatment conditioner DRUG

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

0.15% ivermectin; 0.25% ivermectin; 0.50% ivermectin

Placebo, vehicle control DRUG

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

Placebo

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Topaz Pharmaceuticals Inc: lead

Study Sites (1)

Global Health Associates of Miami

Miami, Florida, 33143, United States

Location

Related Publications (1)

• 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.

  PMID: 23278618 DERIVED

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Topaz

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Topaz

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 9, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: March 30, 2012
• Results First Posted: March 30, 2012

Record last verified: 2012-03

Locations

US (1)