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A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00528021
Recruitment Status : Completed
First Posted : September 11, 2007
Results First Posted : December 28, 2010
Last Update Posted : December 28, 2010
Sponsor:
Information provided by:
BTG International Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Pediculus Humanus Capitis
Head Lice
Interventions Drug: Placebo
Drug: BGC20-0582
Enrollment 230
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 2.5% BGC20-0582 10% BGC20-0582 12.5% BGC20-0582 Vehicle
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 59 59 56 56
Completed 42 46 49 47
Not Completed 17 13 7 9
Reason Not Completed
Lack of Efficacy             17             13             7             9
Arm/Group Title 2.5% BGC20-0582 10% BGC20-0582 12.5% BGC20-0582 Vehicle Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 59 59 56 56 230
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 56 participants 56 participants 230 participants
<=18 years
55
  93.2%
56
  94.9%
55
  98.2%
55
  98.2%
221.0
Between 18 and 65 years
4
   6.8%
3
   5.1%
1
   1.8%
1
   1.8%
9.0
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0.0
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 59 participants 56 participants 56 participants 230 participants
12.3  (11.5) 13.5  (12.1) 13  (10.2) 12.3  (8.8) 12.8  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 59 participants 56 participants 56 participants 230 participants
Female
54
  91.5%
54
  91.5%
49
  87.5%
49
  87.5%
206.0
Male
5
   8.5%
5
   8.5%
7
  12.5%
7
  12.5%
24.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 59 participants 59 participants 56 participants 56 participants 230 participants
59 59 56 56 230
1.Primary Outcome
Title Clinical Cure
Hide Description No live lice 14 days following last treatment
Time Frame Day 15 or 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2.5% BGC20-0582 10% BGC20-0582 12.5% BGC20-0582 Vehicle
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 42 46 49 47
Measure Type: Number
Unit of Measure: participant
30 28 35 32
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2.5% BGC20-0582 10% BGC20-0582 12.5% BGC20-0582 Vehicle
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
2.5% BGC20-0582 10% BGC20-0582 12.5% BGC20-0582 Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
2.5% BGC20-0582 10% BGC20-0582 12.5% BGC20-0582 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/59 (0.00%)      0/56 (0.00%)      0/56 (0.00%)      0/59 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
2.5% BGC20-0582 10% BGC20-0582 12.5% BGC20-0582 Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/59 (22.03%)      10/56 (17.86%)      16/56 (28.57%)      11/59 (18.64%)    
General disorders         
Application site irritation   8/59 (13.56%)  8 5/56 (8.93%)  5 8/56 (14.29%)  8 3/59 (5.08%)  3
Application site pruritis   4/59 (6.78%)  4 2/56 (3.57%)  2 2/56 (3.57%)  2 5/59 (8.47%)  5
Skin and subcutaneous tissue disorders         
Dandruff   3/59 (5.08%)  3 5/56 (8.93%)  5 8/56 (14.29%)  8 5/59 (8.47%)  5
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Thomas Logan Ph.D.
Organization: BTG International
Phone: 610-943-3518
Responsible Party: Tom Logan, BTG
ClinicalTrials.gov Identifier: NCT00528021     History of Changes
Other Study ID Numbers: BCG20-0582-001
First Submitted: September 10, 2007
First Posted: September 11, 2007
Results First Submitted: February 20, 2009
Results First Posted: December 28, 2010
Last Update Posted: December 28, 2010