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Topical ASC-J9 Cream for Acne

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ClinicalTrials.gov Identifier: NCT01289574
Recruitment Status : Completed
First Posted : February 3, 2011
Results First Posted : July 25, 2014
Last Update Posted : August 1, 2014
Sponsor:
Collaborator:
Orient Europharma Co., Ltd.
Information provided by (Responsible Party):
AndroScience Corp

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne
Intervention Drug: ASC-J9
Enrollment 181
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vehicle Control Cream 0.025% ASC-J9 Cream 0.1% ASC-J9 Cream
Hide Arm/Group Description ASC-J9: Cream for twice daily topical application to the face ASC-J9: Cream for twice daily topical application to the face ASC-J9: Cream for twice daily topical application to the face
Period Title: Overall Study
Started 58 60 63
Completed 51 57 60
Not Completed 7 3 3
Reason Not Completed
Lack of Efficacy             4             0             1
Lost to Follow-up             2             0             1
Withdrawal by Subject             1             1             1
Adverse Event             0             1             0
Subject wanted alternate treatment             0             1             0
Arm/Group Title Vehicle Control Cream 0.025% ASC-J9 Cream 0.1% ASC-J9 Cream Total
Hide Arm/Group Description ASC-J9: Cream for twice daily topical application to the face ASC-J9: Cream for twice daily topical application to the face ASC-J9: Cream for twice daily topical application to the face Total of all reporting groups
Overall Number of Baseline Participants 58 60 63 181
Hide Baseline Analysis Population Description
Randomized subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 58 participants 60 participants 63 participants 181 participants
21.1  (5.7) 20.7  (4.8) 22.0  (6.3) 21.3  (5.6)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 60 participants 63 participants 181 participants
<=18 years
18
  31.0%
18
  30.0%
22
  34.9%
58
  32.0%
Between 18 and 65 years
40
  69.0%
42
  70.0%
41
  65.1%
123
  68.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 60 participants 63 participants 181 participants
Female
31
  53.4%
23
  38.3%
32
  50.8%
86
  47.5%
Male
27
  46.6%
37
  61.7%
31
  49.2%
95
  52.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 60 participants 63 participants 181 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
44
  75.9%
48
  80.0%
49
  77.8%
141
  77.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   1.7%
3
   4.8%
4
   2.2%
White
14
  24.1%
10
  16.7%
11
  17.5%
35
  19.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   1.7%
0
   0.0%
1
   0.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 58 participants 60 participants 63 participants 181 participants
Hispanic or Latino
2
   3.4%
2
   3.3%
1
   1.6%
5
   2.8%
Not Hispanic or Latino
56
  96.6%
58
  96.7%
62
  98.4%
176
  97.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 58 participants 60 participants 63 participants 181 participants
United States 14 13 15 42
Taiwan 44 47 48 139
1.Primary Outcome
Title Percent Change in Inflammatory Acne Lesion Counts
Hide Description Percent change from Baseline
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Vehicle Control Cream 0.025% ASC-J9 Cream 0.1% ASC-J9 Cream
Hide Arm/Group Description:
Vehicle control cream for twice daily topical application to the face
ASC-J9: Cream for twice daily topical application to the face
ASC-J9: Cream for twice daily topical application to the face
Overall Number of Participants Analyzed 58 60 63
Mean (Standard Deviation)
Unit of Measure: Percentage change from baseline
-28.6  (52.2) -44.3  (31.7) -44.4  (34.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Control Cream, 0.025% ASC-J9 Cream, 0.1% ASC-J9 Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1919
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel (CMH) row mean score statistics, adjusting for investigational site
2.Secondary Outcome
Title Success on Investigator Global Assessment (IGA) at Week 12
Hide Description

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

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects
Arm/Group Title Vehicle Control Cream 0.025% ASC-J9 Cream 0.1% ASC-J9 Cream
Hide Arm/Group Description:
ASC-J9: Cream for twice daily topical application to the face
ASC-J9: Cream for twice daily topical application to the face
ASC-J9: Cream for twice daily topical application to the face
Overall Number of Participants Analyzed 58 60 63
Measure Type: Number
Unit of Measure: Percentage of subjects
6.9 21.7 17.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Control Cream, 0.025% ASC-J9 Cream, 0.1% ASC-J9 Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0610
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Percent Change in Noninflammatory Acne Lesion Counts
Hide Description Percent change from Baseline
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects
Arm/Group Title Vehicle Control Cream 0.025% ASC-J9 Cream 0.1% ASC-J9 Cream
Hide Arm/Group Description:
Vehicle control cream for twice daily topical application to the face
ASC-J9: Cream for twice daily topical application to the face
ASC-J9: Cream for twice daily topical application to the face
Overall Number of Participants Analyzed 58 60 63
Mean (Standard Deviation)
Unit of Measure: Percentage change from baseline
-18.5  (49.7) -35.5  (39.7) -36.3  (38.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vehicle Control Cream, 0.025% ASC-J9 Cream, 0.1% ASC-J9 Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0857
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame 16 weeks
Adverse Event Reporting Description During 12-week dosing period and for 4 weeks after the last dose.
 
Arm/Group Title Vehicle Control Cream 0.025% ASC-J9 Cream 0.1% ASC-J9 Cream
Hide Arm/Group Description ASC-J9: Cream for twice daily topical application to the face ASC-J9: Cream for twice daily topical application to the face ASC-J9: Cream for twice daily topical application to the face
All-Cause Mortality
Vehicle Control Cream 0.025% ASC-J9 Cream 0.1% ASC-J9 Cream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Vehicle Control Cream 0.025% ASC-J9 Cream 0.1% ASC-J9 Cream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/60 (0.00%)   0/63 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vehicle Control Cream 0.025% ASC-J9 Cream 0.1% ASC-J9 Cream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/58 (0.00%)   0/60 (0.00%)   0/63 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Charles CY Shih, PhD
Organization: AndroScience Corp
Phone: (858) 638-7230
Responsible Party: AndroScience Corp
ClinicalTrials.gov Identifier: NCT01289574     History of Changes
Other Study ID Numbers: ASC-J9-202
First Submitted: February 2, 2011
First Posted: February 3, 2011
Results First Submitted: June 27, 2014
Results First Posted: July 25, 2014
Last Update Posted: August 1, 2014