Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy 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 between 1 and 3 cm long, less than 1 cm at its widest point
- willing to undergo keloid scar removal 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 malignant neoplasm within the last 5 years, except for surgically removed cancers of the skin that are not on the keloid area
- history of anaphylactic shock or anaphylactoid (hypersensitivity) reaction
- allergy to local anesthesia, including lidocaine and epinephrine
- ongoing 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
- donate blood within 7 days before dosing with study drug
- donate plasma within 3 days before dosing with study drug
- have a tattoo within 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 a tanning bed or tanning light within 3 months before enrollment
- intend to use any scar improving product during the study (one year)
- history of drug addiction or excessive use of alcohol
- previous drug treatment of the keloid scar that will be removed within the last 3 years; any laser, irradiation, or surgery of the keloid scar that will be removed
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00825916
Start Date
March 1 2009
End Date
July 1 2010
Last Update
October 11 2012
Active Locations (2)
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1
Paddington Testing Company, Inc.
Philadelphia, Pennsylvania, United States, 19103
2
DermResearch, Inc.
Austin, Texas, United States, 78759