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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AndroScience Corp
ClinicalTrials.gov Identifier:
NCT00525499
First received: August 31, 2007
Last updated: November 16, 2011
Last verified: November 2011
Results First Received: January 31, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acne Vulgaris
Interventions: Drug: ASC-J9 cream
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Vehicle Control     0.001% ASC-J9 Cream     0.005% ASC-J9 Cream     0.025% ASC-J9 Cream  
STARTED     47     46     47     46  
COMPLETED     40     39     40     39  
NOT COMPLETED     7     7     7     7  
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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    Vehicle Control     0.001% ASC-J9 Cream     0.005% ASC-J9 Cream     0.025% ASC-J9 Cream     Total  
Number of Participants  
[units: participants]
  47     46     47     46     186  
Age  
[units: participants]
         
<=18 years     33     33     32     31     129  
Between 18 and 65 years     14     13     15     15     57  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  17.7  ± 4.9     18.0  ± 4.9     17.7  ± 5.8     18.3  ± 5.3     17.9  ± 5.2  
Gender  
[units: participants]
         
Female     14     27     19     16     76  
Male     33     19     28     30     110  
Region of Enrollment  
[units: participants]
         
United States     47     46     47     46     186  



  Outcome Measures
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1.  Primary:   Percent Change in Inflammatory Acne Lesion Counts From Baseline to Week 12   [ Time Frame: Baseline to Week 12 ]

2.  Secondary:   Number of Participants With Improvement in Investigator Global Assessment by at Least One Grade From Baseline to Week 12   [ Time Frame: Baseline to Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Charles CY Shih, PhD
Organization: AndroScience Corp
phone: (858) 638-7230
e-mail: cyshih@androscience.com


No publications provided


Responsible Party: AndroScience Corp
ClinicalTrials.gov Identifier: NCT00525499     History of Changes
Other Study ID Numbers: ASC-J9-201
Study First Received: August 31, 2007
Results First Received: January 31, 2011
Last Updated: November 16, 2011
Health Authority: United States: Food and Drug Administration