Trial Outcomes & Findings for A Study of a New Drug Treatment for Acne (NCT NCT01326780)
NCT ID: NCT01326780
Last Updated: 2019-10-16
Results Overview
Change in lesion counts between baseline and end of study
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
431 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2019-10-16
Participant Flow
18 investigational sites: First patient enrolled: 08 March 2011, Last patient completed: 02 March 2012
male and female subjects with moderate facial acne vulgaris, who met the entry criteria, were randomized with equal allocation to either 1.2%, 2.4%, or 3.6% JNJ 10229570-AAA cream or color-matched vehicle
Participant milestones
| Measure |
0% Facial Cream
Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks
|
1.2% Facial Cream
1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
|
2.4% Facial Cream
2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
|
3.6% Facial Cream
3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
106
|
109
|
109
|
107
|
|
Overall Study
COMPLETED
|
93
|
100
|
103
|
94
|
|
Overall Study
NOT COMPLETED
|
13
|
9
|
6
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of a New Drug Treatment for Acne
Baseline characteristics by cohort
| Measure |
0% Facial Cream
n=106 Participants
Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks
|
1.2% Facial Cream
n=109 Participants
1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
|
2.4% Facial Cream
n=109 Participants
2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
|
3.6% Facial Cream
n=107 Participants
3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
|
Total
n=431 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
19.9 years
STANDARD_DEVIATION 7.6 • n=5 Participants
|
17.3 years
STANDARD_DEVIATION 4 • n=7 Participants
|
19.7 years
STANDARD_DEVIATION 7 • n=5 Participants
|
17.9 years
STANDARD_DEVIATION 5.5 • n=4 Participants
|
18.7 years
STANDARD_DEVIATION 6.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
53 Participants
n=4 Participants
|
198 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
54 Participants
n=4 Participants
|
233 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
106 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
107 Participants
n=4 Participants
|
431 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Change in lesion counts between baseline and end of study
Outcome measures
| Measure |
0% Facial Cream
n=106 Participants
Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks
|
1.2% Facial Cream
n=109 Participants
1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
|
2.4% Facial Cream
n=109 Participants
2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
|
3.6% Facial Cream
n=107 Participants
3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
|
|---|---|---|---|---|
|
Change in Total Acne Lesion Counts
|
-26.0 Lesions
Standard Deviation 27.43
|
-25.2 Lesions
Standard Deviation 30.23
|
-29.4 Lesions
Standard Deviation 30.30
|
-33.1 Lesions
Standard Deviation 29.32
|
SECONDARY outcome
Timeframe: Baseline through Week 12Change in sum of open and closed comedones.
Outcome measures
| Measure |
0% Facial Cream
n=106 Participants
Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks
|
1.2% Facial Cream
n=109 Participants
1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
|
2.4% Facial Cream
n=109 Participants
2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
|
3.6% Facial Cream
n=107 Participants
3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in the Non-inflammatory Acne Lesion Counts
|
-12.6 Lesions
Standard Deviation 20.3
|
-12.0 Lesions
Standard Deviation 21.2
|
-14.3 Lesions
Standard Deviation 20.9
|
-15.3 Lesions
Standard Deviation 21.9
|
SECONDARY outcome
Timeframe: Baseline through Week 12Change in sum of papules and pustules
Outcome measures
| Measure |
0% Facial Cream
n=106 Participants
Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks
|
1.2% Facial Cream
n=109 Participants
1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
|
2.4% Facial Cream
n=109 Participants
2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
|
3.6% Facial Cream
n=107 Participants
3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
|
|---|---|---|---|---|
|
Change From Baseline in the Inflammatory Acne Lesion Counts
|
-13.4 Lesions
Standard Deviation 13.4
|
-13.2 Lesions
Standard Deviation 16.3
|
-15.1 Lesions
Standard Deviation 14.1
|
-18.1 Lesions
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: Baseline through Week 12Percent Change in the Non-Inflammatory Acne Lesion Counts (the sum of open and closed comedones)
Outcome measures
| Measure |
0% Facial Cream
n=106 Participants
Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks
|
1.2% Facial Cream
n=109 Participants
1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
|
2.4% Facial Cream
n=109 Participants
2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
|
3.6% Facial Cream
n=107 Participants
3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
|
|---|---|---|---|---|
|
Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts
|
-28.6 Percent change
Standard Deviation 39.3
|
-21.7 Percent change
Standard Deviation 43.1
|
-31.2 Percent change
Standard Deviation 41.0
|
-30.8 Percent change
Standard Deviation 37.6
|
SECONDARY outcome
Timeframe: Baseline through Week 12Percent Change in Inflammatory Acne Lesion Counts (sum of of papules and pustules)
Outcome measures
| Measure |
0% Facial Cream
n=106 Participants
Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks
|
1.2% Facial Cream
n=109 Participants
1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
|
2.4% Facial Cream
n=109 Participants
2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
|
3.6% Facial Cream
n=107 Participants
3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
|
|---|---|---|---|---|
|
Percent Change From Baseline in the Inflammatory Acne Lesion Counts
|
-39.6 Percent change
Standard Deviation 36.3
|
-35.4 Percent change
Standard Deviation 45.3
|
-44.7 Percent change
Standard Deviation 41.1
|
-48.5 Percent change
Standard Deviation 31.9
|
SECONDARY outcome
Timeframe: Baseline through Week 12.Percent change in Total Acne Lesion Counts (inflammatory lesions and non-inflammatory lesions)
Outcome measures
| Measure |
0% Facial Cream
n=106 Participants
Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks
|
1.2% Facial Cream
n=109 Participants
1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
|
2.4% Facial Cream
n=109 Participants
2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
|
3.6% Facial Cream
n=107 Participants
3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
|
|---|---|---|---|---|
|
Percent Change From Baseline in Total Acne Lesion Counts
|
-33.9 Percent change
Standard Deviation 32.7
|
-27.8 Percent change
Standard Deviation 35.1
|
-36.5 Percent change
Standard Deviation 36.5
|
-37.7 Percent change
Standard Deviation 29.9
|
Adverse Events
0% Facial Cream
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
1.2% Facial Cream
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
2.4% Facial Cream
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
3.6% Facial Cream
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0% Facial Cream
n=106 participants at risk
Vehicle control Vehicle control : Color matched cream vehicle, applied once daily to the face for 12 weeks
|
1.2% Facial Cream
n=109 participants at risk
1.2% JNJ 10229570-AAA 1.2% JNJ 10229570-AAA : 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
|
2.4% Facial Cream
n=109 participants at risk
2.4% JNJ 10229570-AAA 2.4% JNJ 10229570-AAA : 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
|
3.6% Facial Cream
n=107 participants at risk
3.6% JNJ 10229570-AAA 3.6% JNJ 10229570-AAA : 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
nasopharyngitis
|
8.5%
9/106 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
6.4%
7/109 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
2.8%
3/109 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
6.5%
7/107 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
|
Nervous system disorders
Headache
|
0.94%
1/106 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
1.8%
2/109 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
0.00%
0/109 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
3.7%
4/107 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
|
Skin and subcutaneous tissue disorders
Acne
|
3.8%
4/106 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
1.8%
2/109 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
2.8%
3/109 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
0.00%
0/107 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
|
Injury, poisoning and procedural complications
Influenza
|
0.00%
0/106 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
0.92%
1/109 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
3.7%
4/109 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
0.00%
0/107 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.8%
3/106 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
0.00%
0/109 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
0.92%
1/109 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
2.8%
3/107 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
|
Infections and infestations
Nasal Congestion
|
1.9%
2/106 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
2.8%
3/109 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
0.00%
0/109 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
0.00%
0/107 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
|
General disorders
Application Site Pruritis
|
1.9%
2/106 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
1.8%
2/109 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
2.8%
3/109 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
0.93%
1/107 • Through 12 weeks.
Adverse events were monitored throughout the study period starting with the signing of the informed consent until completion of the last study-related procedure.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place