A Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars
NCT ID: NCT00892723
Last Updated: 2012-10-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2009-05-31
2010-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Low Dose
AZX100 Drug Product
Subjects were administered AZX100 0.3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
High Dose
AZX100 Drug Product
Subjects were administered AZX100 10 mg per linear centimeter (high dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
Placebo
Placebo
Subjects were administered placebo (0.9% saline) per linear centimeter intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
Interventions
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AZX100 Drug Product
Subjects were administered AZX100 0.3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
Placebo
Subjects were administered placebo (0.9% saline) per linear centimeter intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
AZX100 Drug Product
Subjects were administered AZX100 10 mg per linear centimeter (high dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
Eligibility Criteria
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Inclusion Criteria
* Willing to undergo keloid scar excision surgery
* Healthy adult male or non-pregnant female
* Non-diabetic
* Body Mass Index in the range of 18-35
* No clinically significant abnormal values on a full blood safety screen
* Non-smoker and non-nicotine user for the previous six months
Exclusion Criteria
* History of cancer within the last 5 years, except for surgically removed cancers of the skin that are not near the keloid area
* History of anaphylactic shock or anaphylactoid (hypersensitivity) reaction
* Allergy to local anesthesia, including lidocaine and epinephrine
* Dermatologic disorders, except for folliculitis and acne
* On therapy with steroids
* On therapy with a drug that would affect collagen synthesis
* Positive urine test for nicotine or drugs of abuse
* Positive blood test for HIV 1 or 2, hepatitis B or hepatitis C
* Positive blood test for anti-AZX100 antibodies
* Participation in another study within 60 days prior to enrollment
* Blood donation within 7 days before dosing with study drug
* Plasma donation within 3 days before dosing with study drug
* Tattoo within approximately 3 cm of the keloid scar that will be removed
* Apply any lotion or cream on or near the keloid scar that will be removed within 14 days before dosing with study drug
* Use of a tanning bed or tanning light within the 3 months before enrollment
* Intend to use any scar improving product during of the study (1 year)
* History of drug addiction or excessive use of alcohol
* Previous drug treatment of the keloid scar within the last 3 years, or have had any laser, irradiation, or surgical treatment of the keloid scar that will be removed
18 Years
65 Years
ALL
No
Sponsors
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Capstone Therapeutics
INDUSTRY
Responsible Party
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Locations
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Lotus Clinical Research, Inc.
Pasadena, California, United States
Paddington Testing Company, Inc.
Philadelphia, Pennsylvania, United States
DermResearch, Inc.
Austin, Texas, United States
Countries
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Other Identifiers
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OL-ASCAR-05
Identifier Type: -
Identifier Source: org_study_id