Clinical trial NCT00811577: A Phase 2a Study to Evaluate the Safety and Efficacy of AZX100 in Trocar Sites of Arthroscopic Shoulder Surgery Patients
Official title: A Phase 2a Double Blind, Placebo Within-Patient Controlled, Multi-Center Dose Ranging Study to Evaluate the Safety and Preliminary Efficacy of AZX100 Drug Product in Trocar Sites of Arthroscopic Shoulder Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scar Prevention
Scar Reduction
Keywords: AZX100
Patient and Observer Scar Assessment Scale
POSAS
Visual Analog Scale
VAS
Trocar
Scarring
Scar reduction
Scar prevention
Lead sponsor: Capstone Therapeutics
Sponsor class: INDUSTRY
First posted: 2008-12-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 arthroscopic shoulder surgery.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores
timeFrame: 12 months
Secondary outcomes:
measure: Between-group Mean Differences in Visual Analog Scale Scores Rated by Independent Blinded Raters Using 3D Photography
timeFrame: 12 months
measure: Between-group Mean Differences in Objective Measures Via 3D Photography (Elevation, Length, Width)
timeFrame: 12 months
measure: Between-group Mean Differences in Objective Measures Via 3D Photography (Volume)
timeFrame: 12 months
measure: Histological Evaluation of Collagen
timeFrame: 12 months
measure: Histological Evaluation of Number of Alpha Smooth Muscle Actin Cells
timeFrame: 12 months
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Lotus Clinical Research, Inc.
state: California
city: Deland
country: United States
facility: Florida Research Associates
state: Florida
city: Orlando
country: United States
facility: Atlas Orthopedics & Sports Medicine
state: Florida
city: Greenville
country: United States
facility: Orthopaedics East, PA
state: North Carolina
city: Austin
country: United States
facility: Texas Orthopedics, Sports & Rehab Assoc.
state: Texas
Study officials:
References: