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

COMPLETEDPHASE2

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

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

NCT00811577•Capstone Therapeutics

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

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
+7 more criteria

Locations (5)

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

Key Dates

Start Date

January 1, 2009

Primary Completion Date

December 1, 2010

Completion Date

December 1, 2010

Last Updated

October 11, 2012

Enrollment

150

ACTUAL participants

Conditions

Scar PreventionScar Reduction

Interventions

Placebo

DRUG

AZX100

DRUG

Combined Intense Pulsed Light (IPL) With Fractional Erbium:YAG Laser Ablation in Scar Prevention

NCT04722705

Intense Pulsed LightErbium-yttrium Aluminum Garnet Laser+1 more

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COMPLETEDPHASE2

A Study to Evaluate the Safety and Efficacy of AZX100 Drug Product Following Excision of Keloid Scars

NCT00825916

Scar PreventionScar Reduction

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 11, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Combined Intense Pulsed Light (IPL) With Fractional Erbium:YAG Laser Ablation in Scar Prevention

A Study to Evaluate the Safety and Efficacy of AZX100 Drug Product Following Excision of Keloid Scars

A Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars