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A Study to Evaluate the Safety and Efficacy of AZX100 Drug Product Following Excision of Keloid Scars

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Capstone Therapeutics
ClinicalTrials.gov Identifier:
NCT00825916
First received: January 20, 2009
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
Results First Received: May 17, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Scar Prevention
Scar Reduction
Interventions: Drug: AZX100 Drug Product
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
Enrollment in the study began in April 2009 and was completed in August 2009. All patients were enrolled at dermatological medical clinics.

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
High Dose AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
Placebo Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
Low Dose AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.

Participant Flow:   Overall Study
    High Dose     Placebo     Low Dose  
STARTED     19     20     20  
COMPLETED     15     18     19  
NOT COMPLETED     4     2     1  
Lost to Follow-up                 4                 2                 1  



  Baseline Characteristics
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Reporting Groups
  Description
High Dose AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
Placebo Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
Low Dose AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
Total Total of all reporting groups

Baseline Measures
    High Dose     Placebo     Low Dose     Total  
Number of Participants  
[units: participants]
 		  19     20     20     59  
Age  
[units: participants]
 		       
<=18 years     0     0     0     0  
Between 18 and 65 years     19     20     20     59  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  38.2  ± 11.1     37.5  ± 11.7     38.2  ± 11.1     37.9  ± 11.3  
Gender  
[units: participants]
 		       
Female     5     7     3     15  
Male     14     13     17     44  
Region of Enrollment  
[units: participants]
 		       
United States     19     20     20     59  



  Outcome Measures
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1.  Primary:   Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores   [ Time Frame: 12 Months ]
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2.  Secondary:   Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters   [ Time Frame: 12 months ]
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3.  Secondary:   Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)   [ Time Frame: 12 months ]
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4.  Secondary:   Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)   [ Time Frame: 12 months ]
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  Serious Adverse Events
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  Other Adverse Events
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Denise Lamon, Director of Regulatory Affairs
Organization: Capstone Therapeutics
phone: 800-937-5520 ext 5206
e-mail: dlamon@capstonethx.com


No publications provided


Responsible Party: Capstone Therapeutics
ClinicalTrials.gov Identifier: NCT00825916     History of Changes
Other Study ID Numbers: OL-ASCAR-04
Study First Received: January 20, 2009
Results First Received: May 17, 2012
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration