A Phase 2a Study to Evaluate the Safety and Efficacy of AZX100 in Trocar Sites of Arthroscopic Shoulder Surgery Patients

NCT ID: NCT00811577

Last Updated: 2012-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-12-31

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.

Conditions

Scar Prevention; Scar Reduction

Keywords

AZX100; Patient and Observer Scar Assessment Scale; POSAS; Visual Analog Scale; VAS; Trocar; Scarring; Scar reduction; Scar prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

AZX100-placebo

Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive one low dose of AZX100 3 mg/linear cm, one high dose of AZX100 10 mg/linear cm, or placebo (saline).

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Patients in the Placebo-only arm were dosed intradermally with placebo (saline) in three trocar sites on Day 9 (plus/minus 2 days) and Day 21 (plus/minus 2 days) after arthroscopic shoulder surgery. In the AZX100-placebo arm, 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.

AZX100

Intervention Type: DRUG

AZX100 Drug Product 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.

Placebo-only

Three trocar sites on each patient received one dose of placebo (saline).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients in the Placebo-only arm were dosed intradermally with placebo (saline) in three trocar sites on Day 9 (plus/minus 2 days) and Day 21 (plus/minus 2 days) after arthroscopic shoulder surgery. In the AZX100-placebo arm, 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.

Interventions

Placebo

Patients in the Placebo-only arm were dosed intradermally with placebo (saline) in three trocar sites on Day 9 (plus/minus 2 days) and Day 21 (plus/minus 2 days) after arthroscopic shoulder surgery. In the AZX100-placebo arm, 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.

Intervention Type: DRUG

AZX100

AZX100 Drug Product 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Capstone Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

Other Identifiers

OL-ASCAR-03

Identifier Type: -

Identifier Source: org_study_id