Trial Outcomes & Findings for Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies. (NCT NCT02978508)
NCT ID: NCT02978508
Last Updated: 2020-09-02
Results Overview
To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
140 participants
Primary outcome timeframe
Day 28
Results posted on
2020-09-02
Participant Flow
Participant milestones
| Measure |
Permethrin Cream, 5%
Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.
Permethrin Cream, 5%: Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
|
Elimite
Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. ("Prestium"), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.
Elimite: Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
COMPLETED
|
70
|
70
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bio-equivalence Study Comparing Permethrin Cream, 5% With Elimite in Patients With Active Scabies.
Baseline characteristics by cohort
| Measure |
Permethrin Cream, 5%
n=70 Participants
Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.
Permethrin Cream, 5%: Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
|
Elimite
n=70 Participants
Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. ("Prestium"), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.
Elimite: Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 15.70 • n=5 Participants
|
36.7 years
STANDARD_DEVIATION 16.23 • n=7 Participants
|
36.3 years
STANDARD_DEVIATION 15.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
131 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
|
|
Visual Examination of Lesions
|
70 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28Population: 2 subjects were not included in the per protocol anaylis for the following reasons: 101-036: Subject rinsed off the IP after 6:45 mins of application. As per protocol IP is to be rinsed off after at least 8-14 hours of application. 103003: Subject's visit 3 and 5 was performed out of allowed visit window period.
To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.
Outcome measures
| Measure |
Permethrin Cream, 5%
n=68 Participants
Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.
Permethrin Cream, 5%: Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
|
Elimite
n=70 Participants
Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. ("Prestium"), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.
Elimite: Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
|
|---|---|---|
|
Proportion of Patients That Are Identified as Cured.
|
68 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: Day 14Population: 2 subjects were not included in the per protocol anaylis for the following reasons: 101-036: Subject rinsed off the IP after 6:45 mins of application. As per protocol IP is to be rinsed off after at least 8-14 hours of application. 103003: Subject's visit 3 and 5 was performed out of allowed visit window period.
To demonstrate bioequivalence between Permethrin Cream, 5% (Test) and Elimite™ (Reference) in patients with active scabies.
Outcome measures
| Measure |
Permethrin Cream, 5%
n=68 Participants
Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.
Permethrin Cream, 5%: Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
|
Elimite
n=70 Participants
Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. ("Prestium"), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.
Elimite: Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
|
|---|---|---|
|
Proportion of Patients That Are Identified as Cured.
|
19 Participants
|
21 Participants
|
Adverse Events
Permethrin Cream, 5%
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Elimite
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Permethrin Cream, 5%
n=70 participants at risk
Permethrin Cream 5%, topical cream, 60g, maximum of two doses over 28 day treatment duration.
Permethrin Cream, 5%: Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
|
Elimite
n=70 participants at risk
Elimite™ 60g, topical, marketed by Prestium Pharma, Inc. ("Prestium"), the branded subsidiary of Renaissance Pharma, maximum of two doses over 28 day treatment duration.
Elimite: Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
2.9%
2/70 • 7 months from first subject first visit.
|
2.9%
2/70 • 7 months from first subject first visit.
|
|
Infections and infestations
Upper Respiratory tract infection
|
0.00%
0/70 • 7 months from first subject first visit.
|
1.4%
1/70 • 7 months from first subject first visit.
|
|
Nervous system disorders
Burning Sensation
|
1.4%
1/70 • 7 months from first subject first visit.
|
1.4%
1/70 • 7 months from first subject first visit.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.4%
1/70 • 7 months from first subject first visit.
|
0.00%
0/70 • 7 months from first subject first visit.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/70 • 7 months from first subject first visit.
|
1.4%
1/70 • 7 months from first subject first visit.
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
1.4%
1/70 • 7 months from first subject first visit.
|
0.00%
0/70 • 7 months from first subject first visit.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.4%
1/70 • 7 months from first subject first visit.
|
0.00%
0/70 • 7 months from first subject first visit.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
1.4%
1/70 • 7 months from first subject first visit.
|
0.00%
0/70 • 7 months from first subject first visit.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.4%
1/70 • 7 months from first subject first visit.
|
1.4%
1/70 • 7 months from first subject first visit.
|
Additional Information
Associate Director, Clinical Operations
Mayne Pharma LLC
Phone: 919 573 7948
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place