Trial Outcomes & Findings for Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis (NCT NCT02791308)
NCT ID: NCT02791308
Last Updated: 2020-05-29
Results Overview
Percentage of subjects in each treatment group with treatment success, defined as a grade of clear or almost clear (a score of 0 or 1 on the IGA) within all treatment areas at the end of treatment on Visit 4/Day 15
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
587 participants
Primary outcome timeframe
15 days
Results posted on
2020-05-29
Participant Flow
Participant milestones
| Measure |
Pimecrolimus Cream, 1%
Pimecrolimus Cream, 1% (Actavis)
Pimecrolimus Cream, 1%
|
Elidel Cream, 1%
Reference listed drug: Elidel 1% cream (Valeant Pharmaceuticals North America LLC)
Pimecrolimus Cream 1% (Valeant)
|
Vehicle Cream
Cream vehicle of the test product (Actavis)
Vehicle cream
|
|---|---|---|---|
|
Overall Study
STARTED
|
195
|
196
|
196
|
|
Overall Study
COMPLETED
|
185
|
187
|
179
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
Pimecrolimus Cream, 1%
n=192 Participants
Pimecrolimus Cream, 1% (Actavis)
Pimecrolimus Cream, 1%
|
Elidel Cream, 1%
n=191 Participants
Reference listed drug: Elidel 1% cream (Valeant Pharmaceuticals North America LLC)
Pimecrolimus Cream 1% (Valeant)
|
Vehicle Cream
n=194 Participants
Cream vehicle of the test product (Actavis)
Vehicle cream
|
Total
n=577 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 18.16 • n=5 Participants
|
37.4 years
STANDARD_DEVIATION 19.20 • n=7 Participants
|
38.4 years
STANDARD_DEVIATION 18.61 • n=5 Participants
|
36.8 years
STANDARD_DEVIATION 18.69 • n=4 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
338 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
239 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
154 Participants
n=5 Participants
|
153 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
466 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
50 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
|
63 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
191 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
101 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 15 daysPopulation: Per-Protocol Population
Percentage of subjects in each treatment group with treatment success, defined as a grade of clear or almost clear (a score of 0 or 1 on the IGA) within all treatment areas at the end of treatment on Visit 4/Day 15
Outcome measures
| Measure |
Pimecrolimus Cream, 1%
n=164 Participants
Pimecrolimus Cream, 1% (Actavis)
Pimecrolimus Cream, 1%
|
Elidel Cream, 1%
n=162 Participants
Reference listed drug: Elidel 1% cream (Valeant Pharmaceuticals North America LLC)
Pimecrolimus Cream 1% (Valeant)
|
Vehicle Cream
n=156 Participants
Cream vehicle of the test product (Actavis)
Vehicle cream
|
|---|---|---|---|
|
Percentage of Subjects With Treatment Success at Visit 4/Day 15
Success
|
62 Participants
|
71 Participants
|
47 Participants
|
|
Percentage of Subjects With Treatment Success at Visit 4/Day 15
Failure
|
102 Participants
|
91 Participants
|
109 Participants
|
Adverse Events
Pimecrolimus Cream, 1%
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Elidel Cream, 1%
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Vehicle Cream
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pimecrolimus Cream, 1%
n=192 participants at risk
Pimecrolimus Cream, 1% (Actavis)
Pimecrolimus Cream, 1%
|
Elidel Cream, 1%
n=191 participants at risk
Reference listed drug: Elidel 1% cream (Valeant Pharmaceuticals North America LLC)
Pimecrolimus Cream 1% (Valeant)
|
Vehicle Cream
n=194 participants at risk
Cream vehicle of the test product (Actavis)
Vehicle cream
|
|---|---|---|---|
|
Eye disorders
Eye Irritation
|
0.52%
1/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Eye disorders
Eye Swelling
|
0.00%
0/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.52%
1/194 • 4 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.52%
1/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Gastrointestinal disorders
Diverticulum
|
0.52%
1/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/192 • 4 months
|
0.52%
1/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.52%
1/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.52%
1/194 • 4 months
|
|
General disorders
Application site hypersensitivity
|
0.00%
0/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.52%
1/194 • 4 months
|
|
General disorders
Application site pain
|
0.52%
1/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.52%
1/194 • 4 months
|
|
General disorders
Application site perspiration
|
0.52%
1/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
General disorders
Application site pruritus
|
0.52%
1/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.52%
1/194 • 4 months
|
|
General disorders
Application site swelling
|
0.52%
1/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/192 • 4 months
|
0.00%
0/191 • 4 months
|
1.0%
2/194 • 4 months
|
|
Infections and infestations
Cellulitis
|
0.52%
1/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.52%
1/194 • 4 months
|
|
Infections and infestations
Herpes Simplex
|
0.52%
1/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Infections and infestations
Influenza
|
0.52%
1/192 • 4 months
|
0.52%
1/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Infections and infestations
Nasopharyngitis
|
1.0%
2/192 • 4 months
|
1.0%
2/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.52%
1/194 • 4 months
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
3/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.52%
1/194 • 4 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.52%
1/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.52%
1/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.52%
1/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.52%
1/194 • 4 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/192 • 4 months
|
0.52%
1/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Nervous system disorders
Heachache
|
1.6%
3/192 • 4 months
|
0.52%
1/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.52%
1/194 • 4 months
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.52%
1/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.52%
1/194 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.0%
2/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.52%
1/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.00%
0/194 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.52%
1/192 • 4 months
|
0.52%
1/191 • 4 months
|
0.52%
1/194 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.52%
1/194 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
0.52%
1/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.52%
1/194 • 4 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/192 • 4 months
|
0.52%
1/191 • 4 months
|
2.6%
5/194 • 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritis generalised
|
0.00%
0/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.52%
1/194 • 4 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.52%
1/194 • 4 months
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/192 • 4 months
|
0.00%
0/191 • 4 months
|
0.52%
1/194 • 4 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 The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.
- Publication restrictions are in place
Restriction type: OTHER