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Completed

NCT Number: NCT00927472

Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice

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.

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Key information

Conditions

Pediculosis Ectoparasitic Infestations Infections Lice Infestations Parasitic Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigator Site, Bentonville, Arkansas, United States

Loading trial locations.

About this study

This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pharmaceuticals.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed active head lice infestation

Exclusion criteria

  • Allergy to pediculicides or hair care products
  • Scalp conditions other than head lice
  • Previous head lice treatment within the past 4 weeks
  • Current antibiotic treatment

Treatment and study plan

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

Drug

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

Other names: Nix Creme Rinse

Primary outcomes

  1. Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment.

    Time frame: 3 weeks

    Treatment Success was evaluated using the Efficacy Intention to Treat (eITT) (LOCF) Efficacy ITT (eITT) was considered definitive.

    The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7).

    Index subject: 95 from 254 randomized (the youngest subject in the household who met index case criteria( having nits and at least 3 live lice))

  2. Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment

    Time frame: 3 weeks

    Treatment Success in the Efficacy Intention to Treat (eITT) (No LOCF)

    The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7).

  3. Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment

    Time frame: 3 weeks

    Treatment Success in the Per Protocol Population (PPP)

    The PPP included all subjects who complied strictly with the protocol and had outcome data for all required visits. Superiority analysis in the PPP was considered to be supportive.

  4. Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF)

    Time frame: 3 weeks

    Treatment Success in the Modified Intention to Treat (Modified ITT) (LOCF)

    The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF

  5. Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF).

    Time frame: 3 weeks

    Treatment Success in the Modified ITT (non-LOCF)

    The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit.

    Subjects with missing efficacy data were included first with LOCF and then with non-LOCF

Secondary outcomes

  1. Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF))

    Time frame: 3 weeks

    Treatment Success in the Efficacy ITT (LOCF)

    The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.

  2. Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF))

    Time frame: 3 weeks

    Treatment Success in the Efficacy ITT (non LOCF)

    The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.

  3. Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP

    Time frame: 3 weeks

    Treatment Success in the PPP

    The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.

    The evaluations in the PPP was considered supportive.

  4. Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF)

    Time frame: 3 weeks

    Treatment Success in the Modified ITT (LOCF)

    The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.

    The evaluations in the Modified ITT was considered supportive.

  5. Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF)

    Time frame: 3 weeks

    Treatment Success in the Modified ITT (non LOCF)

    The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.

    The evaluations in the Modified ITT was considered supportive.

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 25, 2009
Registry last updated
Aug 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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