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

Capstone Therapeutics

Status and phase: Completed; Phase 2

Conditions: Scar Reduction; Scar Prevention

Treatments: Drug: Placebo; Drug: AZX100

Study type: Interventional

Funder types: Industry

Identifiers

NCT00811577

OL-ASCAR-03

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

AZX100-placebo

Experimental group

Description:

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).

Treatment:

Drug: Placebo

Drug: AZX100

Placebo-only

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo