Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioequivalence Study for Benzyl Alcohol Lotion 5%.

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: NCT02624843
Recruitment Status : Completed
First Posted : December 9, 2015
Results First Posted : September 3, 2020
Last Update Posted : January 27, 2021
Sponsor:
Collaborators:
South Florida Family Health and Research Centers
Axis Clinical Trials
Information provided by (Responsible Party):
Akorn, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Head Lice
Interventions Drug: Benzyl Alcohol Lotion 5%
Drug: Ulesfia (benzyl alcohol lotion) 5%
Drug: Placebo
Enrollment 239
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Benzyl Alcohol Lotion 5% Ulesfia (Benzyl Alcohol Lotion 5%) Vehicle Placebo Lotion 0%
Hide Arm/Group Description

Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.

Benzyl Alcohol Lotion 5%: White topical lotion

Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.

Ulesfia (benzyl alcohol lotion) 5%: White topical lotion

Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.

Placebo: White topical lotion

Period Title: Overall Study
Started 107 108 24
Completed 70 72 16
Not Completed 37 36 8
Arm/Group Title Benzyl Alcohol Lotion 5% Ulesfia (Benzyl Alcohol Lotion 5%) Vehicle Placebo Lotion 0% Total
Hide Arm/Group Description

Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.

Benzyl Alcohol Lotion 5%: White topical lotion

Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.

Ulesfia (benzyl alcohol lotion) 5%: White topical lotion

Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.

Placebo: White topical lotion

Total of all reporting groups
Overall Number of Baseline Participants 107 108 24 239
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 108 participants 24 participants 239 participants
<=18 years
77
  72.0%
85
  78.7%
18
  75.0%
180
  75.3%
Between 18 and 65 years
30
  28.0%
23
  21.3%
6
  25.0%
59
  24.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 108 participants 24 participants 239 participants
Female
102
  95.3%
98
  90.7%
24
 100.0%
224
  93.7%
Male
5
   4.7%
10
   9.3%
0
   0.0%
15
   6.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 107 participants 108 participants 24 participants 239 participants
107 108 24 239
1.Primary Outcome
Title Number of Participants With Infestation Successfully Eliminated by Active Treatment.
Hide Description Successful elimination of infestation by active treatment [Time frame: 22 + 2 days]. No evidence of active head lice infestation 22 days after enrollment.
Time Frame Study Day 22 +/-2
Hide Outcome Measure Data
Hide Analysis Population Description
PP
Arm/Group Title Benzyl Alcohol Lotion 5% Ulesfia (Benzyl Alcohol Lotion 5%) Vehicle Placebo Lotion 0%
Hide Arm/Group Description:

Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.

Benzyl Alcohol Lotion 5%: White topical lotion

Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.

Ulesfia (benzyl alcohol lotion) 5%: White topical lotion

Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.

Placebo: White topical lotion

Overall Number of Participants Analyzed 70 72 16
Measure Type: Count of Participants
Unit of Measure: Participants
59
  84.3%
57
  79.2%
6
  37.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Benzyl Alcohol Lotion 5% Ulesfia (Benzyl Alcohol Lotion 5%) Vehicle Placebo Lotion 0%
Hide Arm/Group Description

Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.

Benzyl Alcohol Lotion 5%: White topical lotion

Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.

Ulesfia (benzyl alcohol lotion) 5%: White topical lotion

Day 1- Sufficient to saturate hair and scalp for 10 min and then washed out. Day 8 -Sufficient to saturate hair and scalp for 10 min and then washed out.

Placebo: White topical lotion

All-Cause Mortality
Benzyl Alcohol Lotion 5% Ulesfia (Benzyl Alcohol Lotion 5%) Vehicle Placebo Lotion 0%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/107 (0.00%)      0/108 (0.00%)      0/24 (0.00%)    
Hide Serious Adverse Events
Benzyl Alcohol Lotion 5% Ulesfia (Benzyl Alcohol Lotion 5%) Vehicle Placebo Lotion 0%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/107 (0.00%)      0/108 (0.00%)      0/24 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Benzyl Alcohol Lotion 5% Ulesfia (Benzyl Alcohol Lotion 5%) Vehicle Placebo Lotion 0%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/107 (1.87%)      1/108 (0.93%)      0/24 (0.00%)    
Eye disorders       
redness of eye * [1]  1/107 (0.93%)  1 0/108 (0.00%)  0 0/24 (0.00%)  0
General disorders       
fever [2]  0/107 (0.00%)  0 1/108 (0.93%)  1 0/24 (0.00%)  0
Skin and subcutaneous tissue disorders       
Skin, nervous system and general disorder * [3]  1/107 (0.93%)  1 0/108 (0.00%)  0 0/24 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
redness of eyes
[2]
fever
[3]
Hot paraesthesia on scalp
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Layout table for Results Point of Contact information
Name/Title: Elisabeth Rivera
Organization: South Florida Family Health & Research
Phone: 3053870051
EMail: elisabeth@sffhrc.com
Layout table for additonal information
Responsible Party: Akorn, Inc.
ClinicalTrials.gov Identifier: NCT02624843    
Other Study ID Numbers: CTHP01
First Submitted: November 25, 2015
First Posted: December 9, 2015
Results First Submitted: August 18, 2020
Results First Posted: September 3, 2020
Last Update Posted: January 27, 2021