Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars
Lead Sponsor:
Capstone Therapeutics
Conditions:
Scar Prevention
Scar Reduction
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study was to determine the safety of AZX100 Drug Product and to determine whether it was effective in preventing or reducing re-growth of surgically removed keloid scars.
Eligibility Criteria
Inclusion
- Keloid scar located below the neck between 1 and 3 cm long and less than 1 cm at its widest point
- 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
- History or clinical evidence of acute or chronic disease
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00892723
Start Date
May 1 2009
End Date
September 1 2010
Last Update
October 11 2012
Active Locations (3)
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1
Lotus Clinical Research, Inc.
Pasadena, California, United States, 91105
2
Paddington Testing Company, Inc.
Philadelphia, Pennsylvania, United States, 19103
3
DermResearch, Inc.
Austin, Texas, United States, 78759