Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 2 Study of ASC-J9 Cream in Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00525499
Recruitment Status : Completed
First Posted : September 5, 2007
Results First Posted : April 18, 2011
Last Update Posted : November 23, 2011
Sponsor:
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 Vulgaris
Interventions Drug: ASC-J9 cream
Drug: placebo
Enrollment 186
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Vehicle Control 0.001% ASC-J9 Cream 0.005% ASC-J9 Cream 0.025% ASC-J9 Cream
Hide Arm/Group Description Vehicle control cream applied topically to the face twice daily for 12 weeks 0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks 0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks 0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
Period Title: Overall Study
Started 47 46 47 46
Completed 40 39 40 39
Not Completed 7 7 7 7
Reason Not Completed
Lost to Follow-up             2             4             1             4
Adverse Event             0             1             0             1
Withdrawal by Subject             5             1             5             2
Protocol Violation             0             1             1             0
Arm/Group Title Vehicle Control 0.001% ASC-J9 Cream 0.005% ASC-J9 Cream 0.025% ASC-J9 Cream Total
Hide Arm/Group Description Vehicle control cream applied topically to the face twice daily for 12 weeks 0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks 0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks 0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 47 46 47 46 186
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 46 participants 47 participants 46 participants 186 participants
<=18 years
33
  70.2%
33
  71.7%
32
  68.1%
31
  67.4%
129
  69.4%
Between 18 and 65 years
14
  29.8%
13
  28.3%
15
  31.9%
15
  32.6%
57
  30.6%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants 46 participants 47 participants 46 participants 186 participants
17.7  (4.9) 18.0  (4.9) 17.7  (5.8) 18.3  (5.3) 17.9  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 46 participants 47 participants 46 participants 186 participants
Female
14
  29.8%
27
  58.7%
19
  40.4%
16
  34.8%
76
  40.9%
Male
33
  70.2%
19
  41.3%
28
  59.6%
30
  65.2%
110
  59.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants 46 participants 47 participants 46 participants 186 participants
47 46 47 46 186
1.Primary Outcome
Title Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12
Hide Description 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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized subjects
Arm/Group Title Vehicle Control 0.001% ASC-J9 Cream 0.005% ASC-J9 Cream 0.025% ASC-J9 Cream
Hide Arm/Group Description:
Vehicle control cream applied topically to the face twice daily for 12 weeks
0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
Overall Number of Participants Analyzed 47 46 47 46
Mean (Standard Deviation)
Unit of Measure: Percent change
-37.4  (41.0) -34.7  (32.4) -30.7  (47.6) -44.8  (35.6)
2.Secondary Outcome
Title Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12
Hide Description

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.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population: All randomized subjects
Arm/Group Title Vehicle Control 0.001% ASC-J9 Cream 0.005% ASC-J9 Cream 0.025% ASC-J9 Cream
Hide Arm/Group Description:
Vehicle control cream applied topically to the face twice daily for 12 weeks
0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
Overall Number of Participants Analyzed 47 46 47 46
Measure Type: Number
Unit of Measure: Participants
23 20 23 28
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Vehicle Control 0.001% ASC-J9 Cream 0.005% ASC-J9 Cream 0.025% ASC-J9 Cream
Hide Arm/Group Description Vehicle control cream applied topically to the face twice daily for 12 weeks 0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks 0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks 0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
All-Cause Mortality
Vehicle Control 0.001% ASC-J9 Cream 0.005% ASC-J9 Cream 0.025% ASC-J9 Cream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Vehicle Control 0.001% ASC-J9 Cream 0.005% ASC-J9 Cream 0.025% ASC-J9 Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/47 (2.13%)      0/46 (0.00%)      0/47 (0.00%)      0/46 (0.00%)    
Infections and infestations         
Viral meningitis * 1  1/47 (2.13%)  1 0/46 (0.00%)  0 0/47 (0.00%)  0 0/46 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Vehicle Control 0.001% ASC-J9 Cream 0.005% ASC-J9 Cream 0.025% ASC-J9 Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/47 (10.64%)      11/46 (23.91%)      8/47 (17.02%)      14/46 (30.43%)    
Infections and infestations         
nasopharyngitis * 1  4/47 (8.51%)  4 4/46 (8.70%)  4 6/47 (12.77%)  6 5/46 (10.87%)  5
Upper respiratory tract infection * 1  1/47 (2.13%)  1 6/46 (13.04%)  6 1/47 (2.13%)  1 6/46 (13.04%)  6
Streptococcal infection * 1  0/47 (0.00%)  0 1/46 (2.17%)  1 1/47 (2.13%)  1 3/46 (6.52%)  3
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The Institution and Investigator agree not to publish the results of this study without the prior written consent of Sponsor.
Results Point of Contact
Name/Title: Charles CY Shih, PhD
Organization: AndroScience Corp
Phone: (858) 638-7230
Responsible Party: AndroScience Corp
ClinicalTrials.gov Identifier: NCT00525499     History of Changes
Other Study ID Numbers: ASC-J9-201
First Submitted: August 31, 2007
First Posted: September 5, 2007
Results First Submitted: January 31, 2011
Results First Posted: April 18, 2011
Last Update Posted: November 23, 2011