Trial Outcomes & Findings for A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris (NCT NCT00525499)
NCT ID: NCT00525499
Last Updated: 2011-11-23
Results Overview
Percent change in inflammatory lesion counts from Baseline to Week 12. It is calculated by taking the Week 12 count minus the Baseline count and then dividing by the Baseline count. Thus, a negative percent change will reflect a reduction in lesion counts.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
186 participants
Primary outcome timeframe
Baseline to Week 12
Results posted on
2011-11-23
Participant Flow
Participant milestones
| Measure |
Vehicle Control
Vehicle control cream applied topically to the face twice daily for 12 weeks
|
0.001% ASC-J9 Cream
0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
0.005% ASC-J9 Cream
0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
0.025% ASC-J9 Cream
0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
46
|
47
|
46
|
|
Overall Study
COMPLETED
|
40
|
39
|
40
|
39
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
7
|
7
|
Reasons for withdrawal
| Measure |
Vehicle Control
Vehicle control cream applied topically to the face twice daily for 12 weeks
|
0.001% ASC-J9 Cream
0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
0.005% ASC-J9 Cream
0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
0.025% ASC-J9 Cream
0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
1
|
4
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
5
|
2
|
|
Overall Study
Protocol Violation
|
0
|
1
|
1
|
0
|
Baseline Characteristics
A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Vehicle Control
n=47 Participants
Vehicle control cream applied topically to the face twice daily for 12 weeks
|
0.001% ASC-J9 Cream
n=46 Participants
0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
0.005% ASC-J9 Cream
n=47 Participants
0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
0.025% ASC-J9 Cream
n=46 Participants
0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
129 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
57 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Age Continuous
|
17.7 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
18.0 years
STANDARD_DEVIATION 4.9 • n=7 Participants
|
17.7 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
18.3 years
STANDARD_DEVIATION 5.3 • n=4 Participants
|
17.9 years
STANDARD_DEVIATION 5.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
76 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
110 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
46 participants
n=7 Participants
|
47 participants
n=5 Participants
|
46 participants
n=4 Participants
|
186 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: ITT population: All randomized subjects
Percent change in inflammatory lesion counts from Baseline to Week 12. It is calculated by taking the Week 12 count minus the Baseline count and then dividing by the Baseline count. Thus, a negative percent change will reflect a reduction in lesion counts.
Outcome measures
| Measure |
Vehicle Control
n=47 Participants
Vehicle control cream applied topically to the face twice daily for 12 weeks
|
0.001% ASC-J9 Cream
n=46 Participants
0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
0.005% ASC-J9 Cream
n=47 Participants
0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
0.025% ASC-J9 Cream
n=46 Participants
0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
|---|---|---|---|---|
|
Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12
|
-37.4 Percent change
Standard Deviation 41.0
|
-34.7 Percent change
Standard Deviation 32.4
|
-30.7 Percent change
Standard Deviation 47.6
|
-44.8 Percent change
Standard Deviation 35.6
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: ITT population: All randomized subjects
The Investigator Global Assessment used a static categorical scale, with zero corresponding to no acne and higher scores reflecting more severe acne: 0 No acne lesions. 1. Rare non-inflammatory lesions. 2. Some non-inflammatory lesions, no more than a few inflammatory lesions. No nodulo-cystic lesions. 3. Many non-inflammatory lesions, some inflammatory lesions, no more than one nodulo-cystic lesion. 4. Many noninflammatory and inflammatory lesions but no more than a few nodulo-cystic lesions. 5. Highly inflammatory lesions, multiple nodulo-cystic lesions.
Outcome measures
| Measure |
Vehicle Control
n=47 Participants
Vehicle control cream applied topically to the face twice daily for 12 weeks
|
0.001% ASC-J9 Cream
n=46 Participants
0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
0.005% ASC-J9 Cream
n=47 Participants
0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
0.025% ASC-J9 Cream
n=46 Participants
0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
|---|---|---|---|---|
|
Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12
|
23 Participants
|
20 Participants
|
23 Participants
|
28 Participants
|
Adverse Events
Vehicle Control
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
0.001% ASC-J9 Cream
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
0.005% ASC-J9 Cream
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
0.025% ASC-J9 Cream
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vehicle Control
n=47 participants at risk
Vehicle control cream applied topically to the face twice daily for 12 weeks
|
0.001% ASC-J9 Cream
n=46 participants at risk
0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
0.005% ASC-J9 Cream
n=47 participants at risk
0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
0.025% ASC-J9 Cream
n=46 participants at risk
0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
|---|---|---|---|---|
|
Infections and infestations
Viral meningitis
|
2.1%
1/47 • Number of events 1 • 16 weeks
|
0.00%
0/46 • 16 weeks
|
0.00%
0/47 • 16 weeks
|
0.00%
0/46 • 16 weeks
|
Other adverse events
| Measure |
Vehicle Control
n=47 participants at risk
Vehicle control cream applied topically to the face twice daily for 12 weeks
|
0.001% ASC-J9 Cream
n=46 participants at risk
0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
0.005% ASC-J9 Cream
n=47 participants at risk
0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
0.025% ASC-J9 Cream
n=46 participants at risk
0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
|
|---|---|---|---|---|
|
Infections and infestations
nasopharyngitis
|
8.5%
4/47 • Number of events 4 • 16 weeks
|
8.7%
4/46 • Number of events 4 • 16 weeks
|
12.8%
6/47 • Number of events 6 • 16 weeks
|
10.9%
5/46 • Number of events 5 • 16 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
1/47 • Number of events 1 • 16 weeks
|
13.0%
6/46 • Number of events 6 • 16 weeks
|
2.1%
1/47 • Number of events 1 • 16 weeks
|
13.0%
6/46 • Number of events 6 • 16 weeks
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/47 • 16 weeks
|
2.2%
1/46 • Number of events 1 • 16 weeks
|
2.1%
1/47 • Number of events 1 • 16 weeks
|
6.5%
3/46 • Number of events 3 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Institution and Investigator agree not to publish the results of this study without the prior written consent of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER