CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 403 enrolled
Drug / intervention
Malathion gel 0.5% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00963508
NCT00963508Phase 3Completed
CompareCT.gov

A Multi-Center Phase III Study to Evaluate Malathion Gel 0.5% Formulation, for the Control of Head Lice in Pediatric Subjects and Adult Subjects With Pediculosis Capitis

Sun Pharmaceutical Industries, Inc.·interventional·Posted Aug 21, 2009·Updated Jun 13, 2014

In Brief

A Phase 3 clinical trial evaluating Malathion gel 0.5% and Permethrin 1% rinse (Nix Crème) for Pediculosis. Completed, enrolled 403 participants across 7 sites.

Detailed Summary

In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPediculosis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 21, 2009
Enrollment StartAug 1, 2009
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.9 years ago

Interventions

Malathion gel 0.5%drug

Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.

Permethrin 1% rinse (Nix Crème)drug

Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present.