Trial Outcomes & Findings for Topical ASC-J9 Cream for Acne (NCT NCT01289574)
NCT ID: NCT01289574
Last Updated: 2014-08-01
Results Overview
Percent change from Baseline
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
181 participants
Primary outcome timeframe
12 weeks
Results posted on
2014-08-01
Participant Flow
Participant milestones
| Measure |
Vehicle Control Cream
ASC-J9: Cream for twice daily topical application to the face
|
0.025% ASC-J9 Cream
ASC-J9: Cream for twice daily topical application to the face
|
0.1% ASC-J9 Cream
ASC-J9: Cream for twice daily topical application to the face
|
|---|---|---|---|
|
Overall Study
STARTED
|
58
|
60
|
63
|
|
Overall Study
COMPLETED
|
51
|
57
|
60
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
3
|
Reasons for withdrawal
| Measure |
Vehicle Control Cream
ASC-J9: Cream for twice daily topical application to the face
|
0.025% ASC-J9 Cream
ASC-J9: Cream for twice daily topical application to the face
|
0.1% ASC-J9 Cream
ASC-J9: Cream for twice daily topical application to the face
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
4
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Subject wanted alternate treatment
|
0
|
1
|
0
|
Baseline Characteristics
Topical ASC-J9 Cream for Acne
Baseline characteristics by cohort
| Measure |
Vehicle Control Cream
n=58 Participants
ASC-J9: Cream for twice daily topical application to the face
|
0.025% ASC-J9 Cream
n=60 Participants
ASC-J9: Cream for twice daily topical application to the face
|
0.1% ASC-J9 Cream
n=63 Participants
ASC-J9: Cream for twice daily topical application to the face
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
21.1 Years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
20.7 Years
STANDARD_DEVIATION 4.8 • n=107 Participants
|
22.0 Years
STANDARD_DEVIATION 6.3 • n=206 Participants
|
21.3 Years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
|
Age, Categorical
<=18 years
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
58 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
123 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
86 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
95 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
44 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
141 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=99 Participants
|
58 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
176 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=99 Participants
|
13 participants
n=107 Participants
|
15 participants
n=206 Participants
|
42 participants
n=7 Participants
|
|
Region of Enrollment
Taiwan
|
44 participants
n=99 Participants
|
47 participants
n=107 Participants
|
48 participants
n=206 Participants
|
139 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: All randomized patients
Percent change from Baseline
Outcome measures
| Measure |
Vehicle Control Cream
n=58 Participants
Vehicle control cream for twice daily topical application to the face
|
0.025% ASC-J9 Cream
n=60 Participants
ASC-J9: Cream for twice daily topical application to the face
|
0.1% ASC-J9 Cream
n=63 Participants
ASC-J9: Cream for twice daily topical application to the face
|
|---|---|---|---|
|
Percent Change in Inflammatory Acne Lesion Counts
|
-28.6 Percentage change from baseline
Standard Deviation 52.2
|
-44.3 Percentage change from baseline
Standard Deviation 31.7
|
-44.4 Percentage change from baseline
Standard Deviation 34.6
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All randomized subjects
Overall acne rated as clear, almost clear, mild, moderate, severe, very severe. Success = Week 12 rating of clear or almost clear and at least a 2-grade improvement from baseline
Outcome measures
| Measure |
Vehicle Control Cream
n=58 Participants
Vehicle control cream for twice daily topical application to the face
|
0.025% ASC-J9 Cream
n=60 Participants
ASC-J9: Cream for twice daily topical application to the face
|
0.1% ASC-J9 Cream
n=63 Participants
ASC-J9: Cream for twice daily topical application to the face
|
|---|---|---|---|
|
Success on Investigator Global Assessment (IGA) at Week 12
|
6.9 Percentage of subjects
|
21.7 Percentage of subjects
|
17.5 Percentage of subjects
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: All randomized subjects
Percent change from Baseline
Outcome measures
| Measure |
Vehicle Control Cream
n=58 Participants
Vehicle control cream for twice daily topical application to the face
|
0.025% ASC-J9 Cream
n=60 Participants
ASC-J9: Cream for twice daily topical application to the face
|
0.1% ASC-J9 Cream
n=63 Participants
ASC-J9: Cream for twice daily topical application to the face
|
|---|---|---|---|
|
Percent Change in Noninflammatory Acne Lesion Counts
|
-18.5 Percentage change from baseline
Standard Deviation 49.7
|
-35.5 Percentage change from baseline
Standard Deviation 39.7
|
-36.3 Percentage change from baseline
Standard Deviation 38.6
|
Adverse Events
Vehicle Control Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.025% ASC-J9 Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.1% ASC-J9 Cream
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place