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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00752973
Other study ID # MALG-0813
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received September 15, 2008
Last updated July 14, 2014
Start date September 2008
Est. completion date January 2012

Study information

Verified date July 2014
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

In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population.

The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date January 2012
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 24 Months
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
MALG (malathion) Treatment
MALG applied for 30 minutes

Locations

Country Name City State
United States Investigator Site Bentonville Arkansas
United States Investigator Site Jonesboro Arkansas

Sponsors (1)

Lead Sponsor Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

References & Publications (1)

Meinking TL, Vicaria M, Eyerdam DH, Villar ME, Reyna S, Suarez G. A randomized, investigator-blinded, time-ranging study of the comparative efficacy of 0.5% malathion gel versus Ovide Lotion (0.5% malathion) or Nix Crème Rinse (1% permethrin) used as labe — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Participants With a Change in Cholinesterase Level at 1 Hour (Day 0). Each patient (aged 6 - 24 months) was assessed at 1 hour (Day 0). The mean percent change (reduction) in plasma and RBC cholinesterase activity from baseline to 1 hr after application was calculated and accompanied by 95% confidence intervals.
If the half-widths of the derived confidence intervals are sufficiently narrow, it will demonstrate that any observed reductions in plasma and RBC cholinesterase activity fall within established safety guidelines.
Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment.
Mean percent change (reduction) = (Post treatment value - Baseline)/ Baseline x100.
Change from Baseline to 1 hour Yes
Primary Participants With a Change in Cholinesterase Level at 24 Hrs (1 Day). Each patient was assessed at Day 1 and the mean percent reduction in plasma and RBC cholinesterase activity from baseline to 24 hr after application was calculated and accompanied by 95% confidence intervals.
Concentration of RBC-cholinesterase (RBC-ChE) and plasma cholinesterase were obtained at baseline, at 1 hr (Day 0) and at 24 hrs (Day 1) after the application of the treatment.
Mean percent reduction = (Post treatment value - Baseline)/ Baseline x100.
Change from baseline to 24 hrs (1 day) Yes
Primary Participants With the Clinical Evidence of Cholinesterase Inhibition Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition.
Abnormal heart rate.
Diarrhea or abdominal cramps.
Inappropriate sweating.
Pupillary miosis (constriction).
Respiratory difficulty such as chest tightness or wheezing.
One participant had wheezing as medical history which continued without increase in severity throughout the treatment.
at Baseline Yes
Primary Participants With the Clinical Evidence of Cholinesterase Inhibition Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence cholinesterase inhibition :
Abnormal heart rate.
Diarrhea or abdominal cramps.
Inappropriate sweating.
Pupillary miosis (constriction).
Respiratory difficulty such as chest tightness or wheezing.
One participants had wheezing as medical history which continued without increase in severity throughout the treatment.
at 1 hr (Day 0) Yes
Primary Participants With the Clinical Evidence of Cholinesterase Inhibition Participants with any of the following symptoms of cholinesterase inhibition as numbered below were considered to have Clinical evidence of cholinesterase inhibition :
Abnormal heart rate.
Diarrhea or abdominal cramps.
Inappropriate sweating.
Pupillary miosis (constriction).
Respiratory difficulty such as chest tightness or wheezing.
One participants had wheezing as medical history which continued without increase in severity throughout the treatment.
at 24 hrs (Day 1) Yes
Primary Participants Clinically Cured of Head Lice 14 Days After Last Treatment No live lice (including adults and nymphs) and nits at Day 7±1 and final lice assessment on either Day 14 (subjects not requiring retreatment) or Day 21 (for retreated subjects). Day 7±1 and Day 14 or Day 21 No
Secondary Evaluation of the Local Safety of Malathion Gel, 0.5% Based Upon Reported Adverse Events and Observed Scalp Reactions. To evaluate the safety of Malathion Gel, 0.5% based upon reported adverse events and observed scalp reactions. Additional safety assessments included eye Irritation. Participants were followed for a minimum of 14 days (1 treatment) and a maximum of 21 days (2 treatments) Yes
See also
  Status Clinical Trial Phase
Completed NCT01660321 - Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation Phase 4
Completed NCT00545753 - Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice Phase 3
Completed NCT00381082 - A Randomised, Assessor-Blind, Comparative Efficacy Clinical Trial of 3 Pediculicides. Phase 2/Phase 3
Terminated NCT02499549 - Two Treatment Regimens of Cocamide DEA Lotion for Head Lice Phase 2/Phase 3
Completed NCT05643820 - Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis Phase 1
Completed NCT00731718 - Control of Head Lice Infestations in Children and Adults N/A
Not yet recruiting NCT01966965 - Efficacy and Safety Study for PIOLIN® Shampoo Phase 3
Completed NCT00927407 - Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice Phase 1
Completed NCT01518699 - Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers Phase 1
Completed NCT00207753 - Effectiveness of Combined Albendazole and Ivermectin Treatment for Intestinal Worm Infections N/A
Completed NCT00927472 - Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice Phase 3
Completed NCT00963508 - Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice Phase 3
Completed NCT01336647 - An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation Phase 2