CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 254 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/NCT00927472
NCT00927472Phase 3Completed
CompareCT.gov

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

Sun Pharmaceutical Industries, Inc.·interventional·Posted Jun 25, 2009·Updated Aug 4, 2014

In Brief

A Phase 3 clinical trial evaluating Malathion gel 0.5% and Permethrin 1% rinse for Pediculosis. Completed, enrolled 254 participants across 2 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 PostedJun 25, 2009
Enrollment StartAug 1, 2009
Primary CompletionMay 1, 2010
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.0 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% rinsedrug

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