CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 78 enrolled
Drug / intervention
ivermectin treatment conditioner +1 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • ✓Age at least 6 months and weight at least 15 kg
  • ✓Confirmed infestation with head lice and viable nits
  • ✓Otherwise in normal state of health
  • ✓Willing and able to attend all scheduled study visits
Key exclusion· 9
  • ✕Treatment for head lice with over-the-counter or prescription agents within 2 weeks prior to enrollment
  • ✕Eczema or other chronic conditions of the scalp and skin
  • ✕Household with more than 5 infested members
  • ✕History of allergy to ivermectin or ingredients in hair products (shampoos, conditioners, styling aids)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00857948
NCT00857948Phase 2Completed
CompareCT.gov

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

Topaz Pharmaceuticals Inc·interventional·Posted Mar 9, 2009·Updated Mar 30, 2012

In Brief

A Phase 2 clinical trial evaluating ivermectin treatment conditioner and Placebo, vehicle control for Pediculus Humanus Capitis (Head Lice). Completed, enrolled 78 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPediculus Humanus Capitis (Head Lice)
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 9, 2009
Enrollment StartMar 1, 2009
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 17.3 years ago

Interventions

ivermectin treatment conditionerdrug

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

Placebo, vehicle controldrug

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