FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2009/091/000266 [Registered on: 19/05/2009]
Last Modified On: 27/03/2012
Post Graduate Thesis   
Type of Trial   
Type of Study    
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to compare the systemic absorption of Malathion when applied locally on hair and scalp as either Malathion Gel 0.5% or Malathion 0.5% Lotion (Ovide) in patients with Head lice 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MALG-0603  Protocol Number 
NCT00927407  ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Nilesh Patel 
Designation   
Affiliation   
Address  Drug Monitoring Research Institute. R-374, TTC, MIDC
Rabale
Mumbai
MAHARASHTRA
400701
India 
Phone  02227642747  
Fax  02227642748  
Email  nileshp@dmricro.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Nilesh Patel 
Designation   
Affiliation  Head of Clinical Operations (Full-time employee of study site) 
Address  Drug Monitoring Research Institute. R-374, TTC, MIDC
Rabale
Mumbai
MAHARASHTRA
400701
India 
Phone  02227642747  
Fax  02227642748  
Email  nileshp@dmricro.com  
 
Details of Contact Person
Public Query  
Name  Dr. Nilesh Patel 
Designation   
Affiliation   
Address  Drug Monitoring Research Institute. R-374, TTC, MIDC
Rabale
Mumbai
MAHARASHTRA
400701
India 
Phone  02227642747  
Fax  02227642748  
Email  nileshp@dmricro.com  
 
Source of Monetary or Material Support  
Taro Pharmaceuticals USA, Inc. 3 Skyline Drive Hawthorne, NY 10532  
 
Primary Sponsor  
Name  Taro Pharmaceuticals USA, Inc. 3 Skyline Drive Hawthorne, NY 10532 Phone: (914) 345-9001 Fax: (914) 345-9719  
Address   
Type of Sponsor   
 
Details of Secondary Sponsor  
Name  Address 
Trident Clinical Research India Pvt. Ltd. B-907, Sagar Tech Plaza Andheri-Kurla Road Saki Naka Andheri (East) Mumbai 400072    
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr. Nilesh Patel  Drug Monitoring Research Institute   Plot No.: R - 374, TTC MIDC,Rabale-400 701
Mumbai
MAHARASHTRA 		 + 91-22-2764 2746 /47/49/50
+ 91-22-2764 2748
nileshp@dmricro.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinical Ethics Forum  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Pediculosis capitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Malathion Gel 0.5%  0.5% malathion to be applied for duration of 30 minutes 
Comparator Agent  Ovide (malathion) 0.5% Lotion  Ovide (malathion) 0.5% lotion To Be Applied For 12 Hour Duration 
 
Inclusion Criteria  
Age From   
Age To   
Gender   
Details  - Adult Male or non-pregnant adult female (age 18 years or older), in good general health - Adult Patients presenting with Pediculosis capitis who meet Inclusion/Exclusion criteria and willing to be enrolled in this study - The Patient must be willing to consent to the treatment with Malathion Gel 0.5% or Ovide Lotion 0.5% and for blood drawings before and after medication administration.  
 
ExclusionCriteria 
Details  - 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  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Compare the Systemic Exposure of Malathion 0.5% Gel versus Ovide 0.5% Lotion 2. Compare the Safety of Both Malathion 0.5% Products  1. Systemic absoption - 48 hours 2. Safety assessment - 07 days  
 
Secondary Outcome  
Outcome  TimePoints 
The link between the systemic exposure and plasma and RBC cholinesterase activity   48 hours 
 
Target Sample Size   Total Sample Size="0"
Sample Size from India="" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   Date Missing 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  02/06/2009 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years=""
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   A randomized, single-dose, parallel group, comparative PK study. Twenty four (24) consenting adult male and female patients, age 18 years and above, 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 systemic exposure and cholinesterase activity in order to check the untoward effect, if any, of Malathion 0.5%. The novel gel formulation is intended to reduce the exposure time of Malathion to human skin from 12 hours from present approved formulation to 30minutes in the test formulation. The hypothesis of proposed study is that the gel formulation is expected to provide better safety by avoiding unintentional exposure to skin by dripping and contact with eye.  
Close