Trial Outcomes & Findings for Clinical Endpoint Study of Ivermectin 1% Cream (NCT NCT02840461)
NCT ID: NCT02840461
Last Updated: 2020-06-02
Results Overview
Bioequivalence of the test to reference was considered to have been demonstrated if the 90% confidence interval for the test to reference ratio for the percent change from baseline to Week 12 in the number of inflamed lesion counts was within \[80%, 125%\].
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
630 participants
Primary outcome timeframe
Baseline and 12 Weeks
Results posted on
2020-06-02
Participant Flow
Participant milestones
| Measure |
Ivermectin Cream, 1%
Test product, manufactured by Actavis Laboratories UT, Inc.
Ivermectin Cream, 1%
|
SoolantraTM (Ivermectin) Cream, 1%
Reference product, manufactured by Galderma Laboratories, L.P.
Ivermectin Cream, 1%
|
Placebo/Vehicle Cream
Placebo, manufactured by Actavis Laboratories UT, Inc.
Placebo/Vehicle cream
|
|---|---|---|---|
|
Overall Study
STARTED
|
259
|
257
|
114
|
|
Overall Study
COMPLETED
|
236
|
235
|
100
|
|
Overall Study
NOT COMPLETED
|
23
|
22
|
14
|
Reasons for withdrawal
| Measure |
Ivermectin Cream, 1%
Test product, manufactured by Actavis Laboratories UT, Inc.
Ivermectin Cream, 1%
|
SoolantraTM (Ivermectin) Cream, 1%
Reference product, manufactured by Galderma Laboratories, L.P.
Ivermectin Cream, 1%
|
Placebo/Vehicle Cream
Placebo, manufactured by Actavis Laboratories UT, Inc.
Placebo/Vehicle cream
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
10
|
7
|
6
|
|
Overall Study
Non-Comliance with Dosing Requirements
|
0
|
1
|
0
|
|
Overall Study
Protocol Violation
|
2
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
10
|
6
|
2
|
|
Overall Study
Worsening of Symptom & Kit Error
|
0
|
0
|
2
|
Baseline Characteristics
Clinical Endpoint Study of Ivermectin 1% Cream
Baseline characteristics by cohort
| Measure |
Ivermectin Cream, 1%
n=259 Participants
Test product, manufactured by Actavis Laboratories UT, Inc.
Ivermectin Cream, 1%
|
SoolantraTM (Ivermectin) Cream, 1%
n=257 Participants
Reference product, manufactured by Galderma Laboratories, L.P.
Ivermectin Cream, 1%
|
Placebo/Vehicle Cream
n=114 Participants
Placebo, manufactured by Actavis Laboratories UT, Inc.
Placebo/Vehicle cream
|
Total
n=630 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.8 years
STANDARD_DEVIATION 15.4 • n=5 Participants
|
50.3 years
STANDARD_DEVIATION 15.0 • n=7 Participants
|
51.1 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
51.1 years
STANDARD_DEVIATION 14.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
182 Participants
n=5 Participants
|
182 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
449 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
181 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
136 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
334 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
296 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
253 Participants
n=5 Participants
|
253 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
620 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Modified Intent-to-Treat Population
Bioequivalence of the test to reference was considered to have been demonstrated if the 90% confidence interval for the test to reference ratio for the percent change from baseline to Week 12 in the number of inflamed lesion counts was within \[80%, 125%\].
Outcome measures
| Measure |
Ivermectin Cream, 1%
n=251 Participants
Test product, manufactured by Actavis Laboratories UT, Inc.
Ivermectin Cream, 1%
|
SoolantraTM (Ivermectin) Cream, 1%
n=248 Participants
Reference product, manufactured by Galderma Laboratories, L.P.
Ivermectin Cream, 1%
|
Vehicle Cream
n=111 Participants
Placebo cream (manufactured by Actavis Laboratories UT, Inc.)
|
|---|---|---|---|
|
Percent Change From Baseline to Week 12 in the Number of Inflamed (Papules/Pustules) Lesions of Rosacea.
|
-64.87 percentage of change from baseline
Standard Error 2.03
|
-64.87 percentage of change from baseline
Standard Error 2.03
|
-55.04 percentage of change from baseline
Standard Error 2.92
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Modified Intent-To-Treat Population
The secondary endpoint was the percentage of patients with a clinical response of "success" using the IGE at Week 12. At Visit 1, the IGE had to be 3 or 4 for the patient to be eligible for inclusion.
Outcome measures
| Measure |
Ivermectin Cream, 1%
n=251 Participants
Test product, manufactured by Actavis Laboratories UT, Inc.
Ivermectin Cream, 1%
|
SoolantraTM (Ivermectin) Cream, 1%
n=248 Participants
Reference product, manufactured by Galderma Laboratories, L.P.
Ivermectin Cream, 1%
|
Vehicle Cream
n=111 Participants
Placebo cream (manufactured by Actavis Laboratories UT, Inc.)
|
|---|---|---|---|
|
The Percentage of Patients With a Clinical Response of "Success".
|
117 Participants
|
108 Participants
|
45 Participants
|
Adverse Events
Ivermectin Cream, 1%
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
SoolantraTM (Ivermectin) Cream, 1%
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo/Vehicle Cream
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ivermectin Cream, 1%
n=259 participants at risk
Test product, manufactured by Actavis Laboratories UT, Inc.
Ivermectin Cream, 1%
|
SoolantraTM (Ivermectin) Cream, 1%
n=257 participants at risk
Reference product, manufactured by Galderma Laboratories, L.P.
Ivermectin Cream, 1%
|
Placebo/Vehicle Cream
n=114 participants at risk
Placebo, manufactured by Actavis Laboratories UT, Inc.
Placebo/Vehicle cream
|
|---|---|---|---|
|
Eye disorders
Dry eye
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Eye disorders
Eye irritation
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Gastrointestinal disorders
Toothache
|
0.39%
1/259 • Number of events 1 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
General disorders
Application site eczema
|
0.00%
0/259 • 6 months
|
0.00%
0/257 • 6 months
|
0.88%
1/114 • Number of events 1 • 6 months
|
|
General disorders
Application site erythema
|
0.00%
0/259 • 6 months
|
0.00%
0/257 • 6 months
|
0.88%
1/114 • Number of events 1 • 6 months
|
|
General disorders
Application site pain
|
0.77%
2/259 • Number of events 3 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
General disorders
Pyrexia
|
0.39%
1/259 • Number of events 1 • 6 months
|
0.00%
0/257 • 6 months
|
0.00%
0/114 • 6 months
|
|
Infections and infestations
Abscess limb
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/259 • 6 months
|
0.00%
0/257 • 6 months
|
0.88%
1/114 • Number of events 1 • 6 months
|
|
Infections and infestations
Bronchitis
|
0.39%
1/259 • Number of events 1 • 6 months
|
0.00%
0/257 • 6 months
|
0.88%
1/114 • Number of events 1 • 6 months
|
|
Infections and infestations
Conjunctivitis
|
0.39%
1/259 • Number of events 1 • 6 months
|
0.00%
0/257 • 6 months
|
0.00%
0/114 • 6 months
|
|
Infections and infestations
Hordeolum
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Infections and infestations
Influenza
|
0.39%
1/259 • Number of events 1 • 6 months
|
0.00%
0/257 • 6 months
|
0.00%
0/114 • 6 months
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
3/259 • Number of events 3 • 6 months
|
0.00%
0/257 • 6 months
|
0.00%
0/114 • 6 months
|
|
Infections and infestations
Oral herpes
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Infections and infestations
Pharyngitis
|
0.39%
1/259 • Number of events 1 • 6 months
|
0.00%
0/257 • 6 months
|
0.00%
0/114 • 6 months
|
|
Infections and infestations
Pnuemonia
|
0.00%
0/259 • 6 months
|
0.00%
0/257 • 6 months
|
0.88%
1/114 • Number of events 1 • 6 months
|
|
Infections and infestations
Sinusitis
|
0.39%
1/259 • Number of events 1 • 6 months
|
0.00%
0/257 • 6 months
|
0.88%
1/114 • Number of events 1 • 6 months
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/259 • 6 months
|
0.00%
0/257 • 6 months
|
0.88%
1/114 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.88%
1/114 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.39%
1/259 • Number of events 1 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/259 • 6 months
|
0.00%
0/257 • 6 months
|
0.88%
1/114 • Number of events 1 • 6 months
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/259 • 6 months
|
0.00%
0/257 • 6 months
|
0.88%
1/114 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.39%
1/259 • Number of events 1 • 6 months
|
0.78%
2/257 • Number of events 2 • 6 months
|
0.00%
0/114 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.77%
2/259 • Number of events 2 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.88%
1/114 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.39%
1/259 • Number of events 1 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/259 • 6 months
|
0.00%
0/257 • 6 months
|
0.88%
1/114 • Number of events 1 • 6 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 2 • 6 months
|
0.00%
0/114 • 6 months
|
|
Nervous system disorders
Headache
|
0.77%
2/259 • Number of events 2 • 6 months
|
1.2%
3/257 • Number of events 6 • 6 months
|
1.8%
2/114 • Number of events 2 • 6 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.39%
1/259 • Number of events 1 • 6 months
|
0.00%
0/257 • 6 months
|
0.00%
0/114 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/259 • 6 months
|
0.78%
2/257 • Number of events 2 • 6 months
|
1.8%
2/114 • Number of events 2 • 6 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 3 • 6 months
|
0.00%
0/114 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/259 • 6 months
|
0.39%
1/257 • Number of events 1 • 6 months
|
0.00%
0/114 • 6 months
|
Additional Information
Senior Director, CE Studies
Teva Pharmaceuticals Inc. USA
Phone: 1-888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place