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

NCT00811577 | Completed Phase 2 Results

• 1 other identifier: OL-ASCAR-03
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores

  Efficacy was based on the difference between mean POSAS scores of placebo and 3 mg AZX100, and placebo and 10 mg AZX100 12 months after shoulder surgery. Three trocar sites were randomized on each patient to receive AZX100 3 mg or AZX100 10 mg or placebo at 9 days and 21 days after shoulder surgery. PSAS results included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS results included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.

  12 months

Secondary Outcomes (5)

• Between-group Mean Differences in Visual Analog Scale Scores Rated by Independent Blinded Raters Using 3D Photography

  12 months

• Between-group Mean Differences in Objective Measures Via 3D Photography (Elevation, Length, Width)

  12 months

• Between-group Mean Differences in Objective Measures Via 3D Photography (Volume)

  12 months

• Histological Evaluation of Collagen

  12 months

• Histological Evaluation of Number of Alpha Smooth Muscle Actin Cells

  12 months

Study Arms (2)

AZX100-placebo

EXPERIMENTAL

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).

Drug: Placebo; Drug: AZX100

Placebo-only

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Placebo 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-placebo; Placebo-only

AZX100 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.

AZX100-placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Capstone Therapeutics: lead

Study Sites (5)

Lotus Clinical Research, Inc.

Pasadena, California, 91105, United States

Location

Florida Research Associates

DeLand, Florida, 32720, United States

Location

Atlas Orthopedics & Sports Medicine

Orlando, Florida, 32822, United States

Location

Orthopaedics East, PA

Greenville, North Carolina, 27834, United States

Location

Texas Orthopedics, Sports & Rehab Assoc.

Austin, Texas, 78759, United States

Location

MeSH Terms

Conditions

Cicatrix

Interventions

AZX 100

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Denise Lamon
• Organization: Capstone Therapeutics Corp.

dlamon@capstonethx.com

602-286-5206

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 11, 2012
• Results First Posted: October 11, 2012

Record last verified: 2012-09

Locations

US (5)