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Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% in the Treatment of Scabies

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ClinicalTrials.gov Identifier: NCT03178942
Recruitment Status : Completed
First Posted : June 7, 2017
Results First Posted : March 14, 2019
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
Novum Pharmaceutical Research Services
Information provided by (Responsible Party):
Encube Ethicals Pvt. Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Scabies
Interventions Drug: Permethrin Cream, 5%
Drug: Elimite™ Cream (permethrin) 5%
Enrollment 254
Recruitment Details Two hundred fifty-four (254) patients were randomized to study products. Thirteen (13) sites randomized patients into the study.The first patient was enrolled on 06/14/2017 and the last patient completed was on 10/30/2017. The time from first patient enrolled until last patient completed was approximately four months.
Pre-assignment Details All eligible patients were randomized at visit 1 and received the study product with instructions for dosing at home.
Arm/Group Title Reference: Elimite™ Cream Test: Permethrin Cream, 5%
Hide Arm/Group Description

Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.)

Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%

Test: Permethrin Cream, 5% (Encube Ethicals)

Permethrin Cream, 5%: Permethrin Cream 5%

Period Title: Overall Study
Started 129 125
Completed 126 123
Not Completed 3 2
Reason Not Completed
Withdrawal by Subject             2             0
Lost to Follow-up             1             2
Arm/Group Title Reference: Elimite™ Cream Test: Permethrin Cream, 5% Total
Hide Arm/Group Description

Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.)

Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%

Test: Permethrin Cream, 5% (Encube Ethicals)

Permethrin Cream, 5%: Permethrin Cream 5%

Total of all reporting groups
Overall Number of Baseline Participants 129 125 254
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 129 participants 125 participants 254 participants
40.7  (21.2) 37.7  (22.4) 39.2  (21.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 125 participants 254 participants
Female
72
  55.8%
73
  58.4%
145
  57.1%
Male
57
  44.2%
52
  41.6%
109
  42.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 125 participants 254 participants
Hispanic or Latino
96
  74.4%
97
  77.6%
193
  76.0%
Not Hispanic or Latino
33
  25.6%
28
  22.4%
61
  24.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 125 participants 254 participants
American Indian or Alaska Native
1
   0.8%
0
   0.0%
1
   0.4%
Asian
3
   2.3%
2
   1.6%
5
   2.0%
Native Hawaiian or Other Pacific Islander
2
   1.6%
0
   0.0%
2
   0.8%
Black or African American
14
  10.9%
15
  12.0%
29
  11.4%
White
109
  84.5%
108
  86.4%
217
  85.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 129 participants 125 participants 254 participants
Puerto Rico 6 6 12
El Salvador 63 62 125
United States 60 57 117
Baseline Severity Score of Nocturnal Itching Pretreatment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 125 participants 254 participants
None
0
   0.0%
0
   0.0%
0
   0.0%
Mild
0
   0.0%
0
   0.0%
0
   0.0%
Moderate
112
  86.8%
110
  88.0%
222
  87.4%
Severe
17
  13.2%
15
  12.0%
32
  12.6%
Baseline Severity of Lesion Count Infestation Pretreatment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 129 participants 125 participants 254 participants
Mild
47
  36.4%
45
  36.0%
92
  36.2%
Moderate
68
  52.7%
57
  45.6%
125
  49.2%
Severe
14
  10.9%
23
  18.4%
37
  14.6%
1.Primary Outcome
Title Number of Patients in Each Treatment Group With Therapeutic Cure (Parasitological Cure Plus Clinical Cure) of Scabies
Hide Description

Parasitological cure is defined as failure to demonstrate microscopically the presence of scabies infestation (i.e., no living mites, no viable mite eggs, and no mite fecal matter present).

Clinical cure is defined as visual evidence of absence of new lesions and healing of original lesions, regardless the presence of post-scabietic nodules (i.e., post-scabietic nodules need not be considered as new lesions or persistence of old lesions).

Time Frame Day 28 ± 4
Hide Outcome Measure Data
Hide Analysis Population Description
The Per Protocol (PP) population was used for the analysis.
Arm/Group Title Reference: Elimite™ Cream Test: Permethrin Cream, 5%
Hide Arm/Group Description:

Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.)

Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%

Test: Permethrin Cream, 5% (Encube Ethicals)

Permethrin Cream, 5%: Permethrin Cream 5%

Overall Number of Participants Analyzed 119 117
Measure Type: Count of Participants
Unit of Measure: Participants
83
  69.7%
86
  73.5%
2.Other Pre-specified Outcome
Title Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days.
Hide Description

Parasitological cure is defined as failure to demonstrate microscopically the presence of scabies infestation (i.e., no living mites, no viable mite eggs, and no mite fecal matter present).

Clinical cure is defined as visual evidence of absence of new lesions and healing of original lesions, regardless the presence of post-scabietic nodules (i.e., post-scabietic nodules need not be considered as new lesions or persistence of old lesions).

Time Frame Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed Visit 2 within 14 ± 2 days and Visit 3 within 28 ± 4 days
Arm/Group Title Reference: Elimite™ Cream Test: Permethrin Cream, 5%
Hide Arm/Group Description:

Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.)

Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%

Test: Permethrin Cream, 5% (Encube Ethicals)

Permethrin Cream, 5%: Permethrin Cream 5%

Overall Number of Participants Analyzed 110 110
Measure Type: Count of Participants
Unit of Measure: Participants
77
  70.0%
81
  73.6%
3.Other Pre-specified Outcome
Title Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Between Day 26 and Day 32, Inclusive.
Hide Description

Parasitological cure is defined as failure to demonstrate microscopically the presence of scabies infestation (i.e., no living mites, no viable mite eggs, and no mite fecal matter present).

Clinical cure is defined as visual evidence of absence of new lesions and healing of original lesions, regardless the presence of post-scabietic nodules (i.e., post-scabietic nodules need not be considered as new lesions or persistence of old lesions).

Time Frame Visit 2 within 14 ± 2 days and Visit 3 between Day 26 and Day 32, inclusive.
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients with a Therapeutic Cure that completed Visit 2 within 14 ± 2 days and Visit 3 between Day 26 and Day 32, inclusive.
Arm/Group Title Reference: Elimite™ Cream Test: Permethrin Cream, 5%
Hide Arm/Group Description:

Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.)

Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%

Test: Permethrin Cream, 5% (Encube Ethicals)

Permethrin Cream, 5%: Permethrin Cream 5%

Overall Number of Participants Analyzed 101 102
Measure Type: Count of Participants
Unit of Measure: Participants
68
  67.3%
75
  73.5%
4.Other Pre-specified Outcome
Title Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days.
Hide Description

Parasitological cure is defined as failure to demonstrate microscopically the presence of scabies infestation (i.e., no living mites, no viable mite eggs, and no mite fecal matter present).

Clinical cure is defined as visual evidence of absence of new lesions and healing of original lesions, regardless the presence of post-scabietic nodules (i.e., post-scabietic nodules need not be considered as new lesions or persistence of old lesions).

Time Frame Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who completed Visit 2 within 14 ± 2 days and Visit 3 within 28 ± 2 days
Arm/Group Title Reference: Elimite™ Cream Test: Permethrin Cream, 5%
Hide Arm/Group Description:

Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.)

Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%

Test: Permethrin Cream, 5% (Encube Ethicals)

Permethrin Cream, 5%: Permethrin Cream 5%

Overall Number of Participants Analyzed 95 100
Measure Type: Count of Participants
Unit of Measure: Participants
65
  68.4%
73
  73.0%
Time Frame 4.5 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Reference: Elimite™ Cream Test: Permethrin Cream, 5%
Hide Arm/Group Description

Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.)

Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%

Test: Permethrin Cream, 5% (Encube Ethicals)

Permethrin Cream, 5%: Permethrin Cream 5%

All-Cause Mortality
Reference: Elimite™ Cream Test: Permethrin Cream, 5%
Affected / at Risk (%) Affected / at Risk (%)
Total   0/129 (0.00%)      0/125 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Reference: Elimite™ Cream Test: Permethrin Cream, 5%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/129 (0.00%)      1/125 (0.80%)    
Infections and infestations     
Left Foot Cellulitus * 1  0/129 (0.00%)  0 1/125 (0.80%)  1
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Reference: Elimite™ Cream Test: Permethrin Cream, 5%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/129 (5.43%)      7/125 (5.60%)    
Gastrointestinal disorders     
Enterocolitis/Acute Colitis * 1  0/129 (0.00%)  0 1/125 (0.80%)  1
Abdominal Pain/Upper Epigastralgia * 1  1/129 (0.78%)  1 0/125 (0.00%)  0
General disorders     
Application Site Hypoaesthesia * 1 [1]  1/129 (0.78%)  1 0/125 (0.00%)  0
Application Site Paraesthesia * 1 [2]  1/129 (0.78%)  1 0/125 (0.00%)  0
Application Site Rash/Rash * 1  1/129 (0.78%)  1 0/125 (0.00%)  0
Infections and infestations     
Viral Upper Respiratory Tract Infection/Common Cold * 1  0/129 (0.00%)  0 1/125 (0.80%)  1
Pharyngitis/Pharyngitis * 1  1/129 (0.78%)  1 0/125 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Pain In Extremity/Leg Pain * 1  0/129 (0.00%)  0 1/125 (0.80%)  1
Bone Pain/Bone Ache * 1  0/129 (0.00%)  0 1/125 (0.80%)  1
Nervous system disorders     
Headache * 1  2/129 (1.55%)  2 2/125 (1.60%)  2
Skin and subcutaneous tissue disorders     
Erythema In Helix Skin Of The Right Ear * 1  0/129 (0.00%)  0 1/125 (0.80%)  1
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
[1]
Right Arm Numbness
[2]
Tingling Sensation In The Skin
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.
In the Clinical Trials Agreements between the sites and the Contract Research Organization, sites are instructed that the Investigator shall not publish, or seek to publish, either in whole or in part any results of the Study without the written consent.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GM-Strategy & Commercial
Organization: Encube Ethicals Pvt ltd
Phone: +91-22-6228-8000 ext 8003
EMail: Pratik.K@EncubeEthicals.com
Layout table for additonal information
Responsible Party: Encube Ethicals Pvt. Ltd.
ClinicalTrials.gov Identifier: NCT03178942     History of Changes
Other Study ID Numbers: 71675502
First Submitted: May 31, 2017
First Posted: June 7, 2017
Results First Submitted: February 15, 2019
Results First Posted: March 14, 2019
Last Update Posted: March 26, 2019