Trial Outcomes & Findings for Multiple-Site Study to Evaluate the Therapeutic Equivalence of Permethrin Cream, 5% in the Treatment of Scabies (NCT NCT03178942)

Last Updated: 2019-03-26

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

254 participants

Primary outcome timeframe

Day 28 ± 4

Results posted on

2019-03-26

Participant Flow

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.

All eligible patients were randomized at visit 1 and received the study product with instructions for dosing at home.

Participant milestones

Participant milestones
Measure	Reference: Elimite™ Cream Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%	Test: Permethrin Cream, 5% Test: Permethrin Cream, 5% (Encube Ethicals) Permethrin Cream, 5%: Permethrin Cream 5%
Overall Study STARTED	129	125
Overall Study COMPLETED	126	123
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Reference: Elimite™ Cream Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%	Test: Permethrin Cream, 5% Test: Permethrin Cream, 5% (Encube Ethicals) Permethrin Cream, 5%: Permethrin Cream 5%
Overall Study Withdrawal by Subject	2	0
Overall Study Lost to Follow-up	1	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reference: Elimite™ Cream n=129 Participants Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%	Test: Permethrin Cream, 5% n=125 Participants Test: Permethrin Cream, 5% (Encube Ethicals) Permethrin Cream, 5%: Permethrin Cream 5%	Total n=254 Participants Total of all reporting groups
Age, Continuous	40.7 years STANDARD_DEVIATION 21.2 • n=5 Participants	37.7 years STANDARD_DEVIATION 22.4 • n=7 Participants	39.2 years STANDARD_DEVIATION 21.8 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants	73 Participants n=7 Participants	145 Participants n=5 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	52 Participants n=7 Participants	109 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	96 Participants n=5 Participants	97 Participants n=7 Participants	193 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	28 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	15 Participants n=7 Participants	29 Participants n=5 Participants
Race (NIH/OMB) White	109 Participants n=5 Participants	108 Participants n=7 Participants	217 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Puerto Rico	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment El Salvador	63 participants n=5 Participants	62 participants n=7 Participants	125 participants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	57 participants n=7 Participants	117 participants n=5 Participants
Baseline Severity Score of Nocturnal Itching Pretreatment None	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Severity Score of Nocturnal Itching Pretreatment Mild	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Severity Score of Nocturnal Itching Pretreatment Moderate	112 Participants n=5 Participants	110 Participants n=7 Participants	222 Participants n=5 Participants
Baseline Severity Score of Nocturnal Itching Pretreatment Severe	17 Participants n=5 Participants	15 Participants n=7 Participants	32 Participants n=5 Participants
Baseline Severity of Lesion Count Infestation Pretreatment Mild	47 Participants n=5 Participants	45 Participants n=7 Participants	92 Participants n=5 Participants
Baseline Severity of Lesion Count Infestation Pretreatment Moderate	68 Participants n=5 Participants	57 Participants n=7 Participants	125 Participants n=5 Participants
Baseline Severity of Lesion Count Infestation Pretreatment Severe	14 Participants n=5 Participants	23 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28 ± 4

Population: The Per Protocol (PP) population was used for the analysis.

Outcome measures

Outcome measures
Measure	Reference: Elimite™ Cream n=119 Participants Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%	Test: Permethrin Cream, 5% n=117 Participants Test: Permethrin Cream, 5% (Encube Ethicals) Permethrin Cream, 5%: Permethrin Cream 5%
Number of Patients in Each Treatment Group With Therapeutic Cure (Parasitological Cure Plus Clinical Cure) of Scabies	83 Participants	86 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days

Population: Patients who completed Visit 2 within 14 ± 2 days and Visit 3 within 28 ± 4 days

Outcome measures

Outcome measures
Measure	Reference: Elimite™ Cream n=110 Participants Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%	Test: Permethrin Cream, 5% n=110 Participants Test: Permethrin Cream, 5% (Encube Ethicals) Permethrin Cream, 5%: Permethrin Cream 5%
Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 4 Days.	77 Participants	81 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 2 within 14 ± 2 days and Visit 3 between Day 26 and Day 32, inclusive.

Population: 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.

Outcome measures

Outcome measures
Measure	Reference: Elimite™ Cream n=101 Participants Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%	Test: Permethrin Cream, 5% n=102 Participants Test: Permethrin Cream, 5% (Encube Ethicals) Permethrin Cream, 5%: Permethrin Cream 5%
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.	68 Participants	75 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days

Population: Patients who completed Visit 2 within 14 ± 2 days and Visit 3 within 28 ± 2 days

Outcome measures

Outcome measures
Measure	Reference: Elimite™ Cream n=95 Participants Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%	Test: Permethrin Cream, 5% n=100 Participants Test: Permethrin Cream, 5% (Encube Ethicals) Permethrin Cream, 5%: Permethrin Cream 5%
Number of Patients With a Therapeutic Cure That Completed Visit 2 Within 14 ± 2 Days and Visit 3 Within 28 ± 2 Days.	65 Participants	73 Participants

Adverse Events

Reference: Elimite™ Cream

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Test: Permethrin Cream, 5%

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Reference: Elimite™ Cream n=129 participants at risk Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%	Test: Permethrin Cream, 5% n=125 participants at risk Test: Permethrin Cream, 5% (Encube Ethicals) Permethrin Cream, 5%: Permethrin Cream 5%
Infections and infestations Left Foot Cellulitus	0.00% 0/129 • 4.5 months	0.80% 1/125 • Number of events 1 • 4.5 months

Other adverse events

Other adverse events
Measure	Reference: Elimite™ Cream n=129 participants at risk Reference: Elimite™ Cream (permethrin) 5% (Prestium Pharma, Inc.) Elimite™ Cream (permethrin) 5%: Permethrin Cream 5%	Test: Permethrin Cream, 5% n=125 participants at risk Test: Permethrin Cream, 5% (Encube Ethicals) Permethrin Cream, 5%: Permethrin Cream 5%
Nervous system disorders Headache	1.6% 2/129 • Number of events 2 • 4.5 months	1.6% 2/125 • Number of events 2 • 4.5 months
Skin and subcutaneous tissue disorders Erythema In Helix Skin Of The Right Ear	0.00% 0/129 • 4.5 months	0.80% 1/125 • Number of events 1 • 4.5 months
Musculoskeletal and connective tissue disorders Pain In Extremity/Leg Pain	0.00% 0/129 • 4.5 months	0.80% 1/125 • Number of events 1 • 4.5 months
Gastrointestinal disorders Enterocolitis/Acute Colitis	0.00% 0/129 • 4.5 months	0.80% 1/125 • Number of events 1 • 4.5 months
Infections and infestations Viral Upper Respiratory Tract Infection/Common Cold	0.00% 0/129 • 4.5 months	0.80% 1/125 • Number of events 1 • 4.5 months
Musculoskeletal and connective tissue disorders Bone Pain/Bone Ache	0.00% 0/129 • 4.5 months	0.80% 1/125 • Number of events 1 • 4.5 months
General disorders Application Site Hypoaesthesia	0.78% 1/129 • Number of events 1 • 4.5 months	0.00% 0/125 • 4.5 months
General disorders Application Site Paraesthesia	0.78% 1/129 • Number of events 1 • 4.5 months	0.00% 0/125 • 4.5 months
Infections and infestations Pharyngitis/Pharyngitis	0.78% 1/129 • Number of events 1 • 4.5 months	0.00% 0/125 • 4.5 months
General disorders Application Site Rash/Rash	0.78% 1/129 • Number of events 1 • 4.5 months	0.00% 0/125 • 4.5 months
Gastrointestinal disorders Abdominal Pain/Upper Epigastralgia	0.78% 1/129 • Number of events 1 • 4.5 months	0.00% 0/125 • 4.5 months

Additional Information

GM-Strategy & Commercial

Encube Ethicals Pvt ltd

Phone: +91-22-6228-8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER