Trial Outcomes & Findings for Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris (NCT NCT01880320)
NCT ID: NCT01880320
Last Updated: 2018-06-28
Results Overview
Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
503 participants
Primary outcome timeframe
Week 12
Results posted on
2018-06-28
Participant Flow
Participant milestones
| Measure |
CD0271 0.3% /CD1579 2.5% Gel
Active arm
CD0271 0.3% / CD1579 2.5%
|
CD0271 0.1% / CD1579 2.5%
Comparator arm
CD0271 0.1% / CD1579 2.5%
|
Topical Gel Vehicle
Placebo arm
Topical Gel Vehicle
|
|---|---|---|---|
|
Overall Study
STARTED
|
217
|
217
|
69
|
|
Overall Study
COMPLETED
|
197
|
192
|
61
|
|
Overall Study
NOT COMPLETED
|
20
|
25
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Multi-center, Randomized, Double-blind Efficacy and Safety of CD0271 0.3%/CD1579 2.5 % Topical Gel in Acne Vulgaris
Baseline characteristics by cohort
| Measure |
CD0271 0.3% /CD1579 2.5% Gel
n=217 Participants
Active arm
CD0271 0.3% / CD1579 2.5%
|
CD0271 0.1% / CD1579 2.5%
n=217 Participants
Comparator arm
CD0271 0.1% / CD1579 2.5%
|
Topical Gel Vehicle
n=69 Participants
Placebo arm
Topical Gel Vehicle
|
Total
n=503 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
124 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
303 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
93 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
20.1 years
STANDARD_DEVIATION 7.59 • n=5 Participants
|
19.4 years
STANDARD_DEVIATION 6.75 • n=7 Participants
|
18.5 years
STANDARD_DEVIATION 5.72 • n=5 Participants
|
19.6 years
STANDARD_DEVIATION 7.01 • n=4 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
263 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
104 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
240 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
5 participants
n=5 Participants
|
38 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
200 participants
n=5 Participants
|
201 participants
n=7 Participants
|
64 participants
n=5 Participants
|
465 participants
n=4 Participants
|
|
Baseline Investigator Global Assessment (IGA)
Baseline IGA = Moderate (3)
|
111 participants
n=5 Participants
|
105 participants
n=7 Participants
|
35 participants
n=5 Participants
|
251 participants
n=4 Participants
|
|
Baseline Investigator Global Assessment (IGA)
Baseline IGA = Severe (4)
|
106 participants
n=5 Participants
|
112 participants
n=7 Participants
|
34 participants
n=5 Participants
|
252 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intent-to-treat (ITT): All subjects who were randomized. Baseline IGA Severe population: All randomized subjects who had IGA=4 at baseline.
Success was defined as 'Clear' or 'Almost Clear' on the Investigator Global Assessment (IGA). Success rate at Week 12 was estimated using multiple imputation approach which is an average of response from multiple imputed datasets.
Outcome measures
| Measure |
CD0271 0.3% /CD1579 2.5% Gel
n=217 Participants
Active arm
CD0271 0.3% / CD1579 2.5%
|
CD0271 0.1% / CD1579 2.5%
n=217 Participants
Comparator arm
CD0271 0.1% / CD1579 2.5%
|
Topical Gel Vehicle
n=69 Participants
Placebo arm
Topical Gel Vehicle
|
|---|---|---|---|
|
Success Rate
All subjects (MI: Multiple Imputation)
|
33.7 percentage of participants
|
27.3 percentage of participants
|
11.0 percentage of participants
|
|
Success Rate
Baseline IGA=Severe (4) (MI: Multiple Imputation)
|
31.9 percentage of participants
|
20.5 percentage of participants
|
11.8 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline - Week12Population: ITT Population, Multiple imputation
Outcome measures
| Measure |
CD0271 0.3% /CD1579 2.5% Gel
n=217 Participants
Active arm
CD0271 0.3% / CD1579 2.5%
|
CD0271 0.1% / CD1579 2.5%
n=217 Participants
Comparator arm
CD0271 0.1% / CD1579 2.5%
|
Topical Gel Vehicle
n=69 Participants
Placebo arm
Topical Gel Vehicle
|
|---|---|---|---|
|
Changes From Baseline in Inflammatory Lesion Counts
All Subjects
|
-27.04 Lesions
Standard Error 0.846
|
-26.72 Lesions
Standard Error 0.822
|
-14.40 Lesions
Standard Error 1.460
|
|
Changes From Baseline in Inflammatory Lesion Counts
Baseline IGA = Severe (4)
|
-35.17 Lesions
Standard Error 1.407
|
-31.92 Lesions
Standard Error 1.320
|
-15.46 Lesions
Standard Error 2.297
|
PRIMARY outcome
Timeframe: Baseline - Week 12Population: ITT Population, Multiple Imputation
Outcome measures
| Measure |
CD0271 0.3% /CD1579 2.5% Gel
n=217 Participants
Active arm
CD0271 0.3% / CD1579 2.5%
|
CD0271 0.1% / CD1579 2.5%
n=217 Participants
Comparator arm
CD0271 0.1% / CD1579 2.5%
|
Topical Gel Vehicle
n=69 Participants
Placebo arm
Topical Gel Vehicle
|
|---|---|---|---|
|
Changes From Baseline in Non-Inflammatory Lesion Counts
All Subjects
|
-40.18 lesions
Standard Error 1.332
|
-39.00 lesions
Standard Error 1.277
|
-18.47 lesions
Standard Error 2.270
|
|
Changes From Baseline in Non-Inflammatory Lesion Counts
Baseline IGA = Severe (4)
|
-45.61 lesions
Standard Error 2.058
|
-43.10 lesions
Standard Error 1.847
|
-17.25 lesions
Standard Error 3.337
|
Adverse Events
CD0271 0.3% /CD1579 2.5% Gel
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
CD0271 0.1% / CD1579 2.5%
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Topical Gel Vehicle
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CD0271 0.3% /CD1579 2.5% Gel
n=217 participants at risk
Active arm
CD0271 0.3% / CD1579 2.5%
|
CD0271 0.1% / CD1579 2.5%
n=217 participants at risk
Comparator arm
CD0271 0.1% / CD1579 2.5%
|
Topical Gel Vehicle
n=69 participants at risk
Placebo arm
Topical Gel Vehicle
|
|---|---|---|---|
|
Psychiatric disorders
Generalized Anxiety Disorder
|
0.00%
0/217
|
0.46%
1/217 • Number of events 1
|
0.00%
0/69
|
Other adverse events
| Measure |
CD0271 0.3% /CD1579 2.5% Gel
n=217 participants at risk
Active arm
CD0271 0.3% / CD1579 2.5%
|
CD0271 0.1% / CD1579 2.5%
n=217 participants at risk
Comparator arm
CD0271 0.1% / CD1579 2.5%
|
Topical Gel Vehicle
n=69 participants at risk
Placebo arm
Topical Gel Vehicle
|
|---|---|---|---|
|
Infections and infestations
Ear infection
|
0.00%
0/217
|
0.00%
0/217
|
1.4%
1/69
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/217
|
0.00%
0/217
|
1.4%
1/69
|
|
Infections and infestations
Nasopharyngitis
|
6.5%
14/217
|
5.1%
11/217
|
1.4%
1/69
|
|
Infections and infestations
Upper respiratory tract infection
|
0.46%
1/217
|
2.3%
5/217
|
5.8%
4/69
|
|
Infections and infestations
Infleunza
|
0.92%
2/217
|
0.92%
2/217
|
1.4%
1/69
|
|
Infections and infestations
Gastroenteritis
|
1.4%
3/217
|
0.46%
1/217
|
0.00%
0/69
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
4.1%
9/217
|
0.46%
1/217
|
0.00%
0/69
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.46%
1/217
|
1.4%
3/217
|
0.00%
0/69
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.4%
3/217
|
0.00%
0/217
|
0.00%
0/69
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.46%
1/217
|
0.00%
0/217
|
1.4%
1/69
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.46%
1/217
|
0.00%
0/217
|
1.4%
1/69
|
|
Nervous system disorders
Headache
|
1.4%
3/217
|
0.92%
2/217
|
1.4%
1/69
|
|
Nervous system disorders
Dizziness
|
0.00%
0/217
|
0.00%
0/217
|
1.4%
1/69
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.46%
1/217
|
0.46%
1/217
|
1.4%
1/69
|
|
Nervous system disorders
Rhinitis seasonal
|
0.00%
0/217
|
0.00%
0/217
|
1.4%
1/69
|
|
General disorders
Fatigue
|
0.00%
0/217
|
0.46%
1/217
|
1.4%
1/69
|
|
General disorders
Pyrexia
|
0.00%
0/217
|
0.00%
0/217
|
1.4%
1/69
|
|
Ear and labyrinth disorders
Motion sickness
|
0.00%
0/217
|
0.00%
0/217
|
1.4%
1/69
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/217
|
0.00%
0/217
|
1.4%
1/69
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place