- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00927407
Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice
December 21, 2013 updated by: Taro Pharmaceuticals USA
A Randomized, Single-Dose, Parallel Group, Comparative Pharmacokinetic (PK) Study to Evaluate Malathion Gel 0.5% Versus Ovide (Malathion) Lotion 0.5% in Patients With Pediculosis Capitis
In this study, 24 adult patients with head lice will be treated with a topical malathion head lice treatment; 12 patients will be treated with a novel product, Malathion Gel, 0.5%, and other 12 patients will be treated with Ovide Lotion 0.5% marketed by Taro Pharmaceuticals USA, Inc.
The primary objective of this study is to compare the blood level exposure of Malathion 0.5% Gel to that of the OVIDE Lotion 0.5%.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A randomized, single-dose, parallel group, comparative PK study.
Patients will be randomly assigned in 1:1 ratio to the study products.
Twenty four (24) consenting patients, age 18 years and older, who meet Inclusion/Exclusion criteria will be enrolled in this study.
12 Patients will be treated with Malathion Gel, 0.5% and other 12 Patients will be treated with Ovide Lotion 0.5%.
The study will be single centre and conducted only in India.
The primary objective of this study is to compare the systemic exposure of Malathion 0.5% Gel manufactured by Taro Pharmaceuticals USA, Inc. to that of the OVIDE Lotion 0.5%, currently marketed by Taro Pharmaceutical USA, Inc., in adult Patients with head lice.
The secondary objective is to determine the link between the exposure and cholinesterase activity.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Navi Mumbai
-
Rabale, Navi Mumbai, India
- Investigator site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or non-pregnant female
- Patients 18 years of age or older and healthy presenting with Pediculosis capitis
- The Patient must be willing to consent to the Patient's treatment with Malathion Gel 0.5% or Ovide Lotion 0.5% and for blood drawings before and after medication administration.
Exclusion Criteria:
- Individuals with history of irritation or sensitivity to pediculicides or hair care products
- Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel, or Sponsor, will interfere with the evaluation.
- Individuals previously treated with a pediculicide within 4 weeks of the study.
- Individuals who exhibit potential signs and symptoms of cholinesterase inhibition.
- Patients currently receiving sulfonamide antibiotics or ivermectin.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Malathion gel 0.05%
Malathion gel 0.5% topical treatment for head lice
|
Malathion gel 0.5% applied to the scalp for 30 minutes
Other Names:
|
Active Comparator: Malathion lotion 0.5%
Malathion lotion 0.5% treatment for head lice
|
Malathion lotion 0.5% applied to scalp for 12 hours
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measurement of blood and urinary levels of malathion and metabolites
Time Frame: 48 hours
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure cholinesterase levels and compare to malathion metabolite levels
Time Frame: 48 hours
|
48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2009
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
June 23, 2009
First Submitted That Met QC Criteria
June 23, 2009
First Posted (Estimate)
June 25, 2009
Study Record Updates
Last Update Posted (Estimate)
December 24, 2013
Last Update Submitted That Met QC Criteria
December 21, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Parasitic Diseases
- Ectoparasitic Infestations
- Skin Diseases, Parasitic
- Skin Diseases, Infectious
- Lice Infestations
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Enzyme Inhibitors
- Cholinesterase Inhibitors
- Malathion
Other Study ID Numbers
- MALG-0603
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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