A Phase 2a Study to Evaluate the Safety and Efficacy of AZX100 in Trocar Sites of Arthroscopic Shoulder Surgery Patients
Completed · Phase 2 · Has a placebo group
Conditions studied: Scar Prevention, Scar Reduction
In brief
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 arthroscopic shoulder surgery.
Key facts
- Study ID
- NCT00811577
- Run by
- Capstone Therapeutics
- People needed
- 150
- Starts
- 2009-01-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2012-10-11
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Lotus Clinical Research, Inc. — Pasadena, California, United States
- Florida Research Associates — DeLand, Florida, United States
- Atlas Orthopedics & Sports Medicine — Orlando, Florida, United States
- Orthopaedics East, PA — Greenville, North Carolina, United States
- Texas Orthopedics, Sports & Rehab Assoc. — Austin, Texas, United States
Full record on ClinicalTrials.gov
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