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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00244439
Other study ID # MALG-0506
Secondary ID
Status Completed
Phase Phase 3
First received October 24, 2005
Last updated December 19, 2013
Start date December 2005
Est. completion date December 2006

Study information

Verified date November 2013
Source Taro Pharmaceuticals USA
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.


Recruitment information / eligibility

Status Completed
Enrollment 360
Est. completion date December 2006
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Both
Age group 2 Years and older
Eligibility Inclusion Criteria:

- Confirmed active head lice infestation

- Patient, parent or guardian must be able to apply the treatment

- Entire household must be screened

- All infested persons must agree to participate

Exclusion Criteria:

- Allergy to pediculicides, hair care products or chrysanthemums

- Scalp conditions other than head lice

- Previous head lice treatment within the past 4 weeks

- Female patients who are pregnant or nursing

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
MALG
30 minute application
Ovide (malathion) lotion 0.05%
8-12 hour application
Permethrin 1%
10 minute application

Locations

Country Name City State
United States Investigator Site Miami Florida
United States Investigator Site Miamiville Ohio
United States Investigator Site New York New York
United States Investigator Site Scottsdale Arizona
United States Investigator Site St. Petersburg Florida
United States Investigator Site West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cure of Head Lice 4 weeks No
Secondary Safety of treatments 4 weeks Yes
See also
  Status Clinical Trial Phase
Terminated NCT00291057 - Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice Phase 2
Completed NCT00819520 - Ivermectin in the Treatment of Head Lice Phase 3
Recruiting NCT05565820 - A Study to Evaluate the Efficacy and Safety of a Leave-in Spray in Subjects With Head Lice Infestation Phase 4