Status:
COMPLETED
A Phase 2a Study to Evaluate the Safety and Efficacy of AZX100 in Trocar Sites of Arthroscopic Shoulder Surgery Patients
Lead Sponsor:
Capstone Therapeutics
Conditions:
Scar Prevention
Scar Reduction
Eligibility:
All Genders
18-75 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 scars that were made from trocars following arthroscopi...
Eligibility Criteria
Inclusion
- Scheduled for an arthroscopic shoulder surgery that will result in at least 3 trocar sites
- Healthy male or non-pregnant female 18-75 years old
- Non-diabetic
- Body Mass Index 18-35
- No clinically significant abnormal values on blood test
- Non-smoker for previous 6 months
Exclusion
- History of acute or chronic disease
- Cancer within previous 5 years, except for removed skin cancer
- Hypersensitivity reaction
- Allergy to general anesthesia, lidocaine, or epinephrine
- Current skin disorder other than folliculitis or acne
- On therapy with steroids
- On therapy with a drug that affects collagen synthesis
- Positive for HIV or hepatitis
- Positive urine test for nicotine
- Positive blood test for anti-AZX100 antibodies
- Participated in another clinical study within 60 days before enrollment
- Gave blood within 7 days before dosing
- Gave plasma within 3 days before dosing
- Tattoo on the shoulder area
- Applied any prescribed or over the counter agents to the shoulder within 14 days before dosing, or intend to use any scar improving product
- Visited a tanning salon within 14 days before dosing
- History of drug addiction or excessive use of alcohol
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00811577
Start Date
January 1 2009
End Date
December 1 2010
Last Update
October 11 2012
Active Locations (5)
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1
Lotus Clinical Research, Inc.
Pasadena, California, United States, 91105
2
Florida Research Associates
DeLand, Florida, United States, 32720
3
Atlas Orthopedics & Sports Medicine
Orlando, Florida, United States, 32822
4
Orthopaedics East, PA
Greenville, North Carolina, United States, 27834