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A Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Pilot Phase 2a Blinded, Placebo Controlled, Multicenter Parallel Group, Dose Ranging Study to Evaluate the Safety and Preliminary Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloids

NCT00892723•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 re-growth of surgically removed keloid scars.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Keloid scar located below the neck between 1 and 3 cm long and less than 1 cm at its widest point
•Willing to undergo keloid scar excision surgery
•Healthy adult male or non-pregnant female
•Non-diabetic
•Body Mass Index in the range of 18-35
•No clinically significant abnormal values on a full blood safety screen
•Non-smoker and non-nicotine user for the previous six months

Exclusion Criteria

•History or clinical evidence of acute or chronic disease
•History of cancer within the last 5 years, except for surgically removed cancers of the skin that are not near the keloid area
•History of anaphylactic shock or anaphylactoid (hypersensitivity) reaction
•Allergy to local anesthesia, including lidocaine and epinephrine
•Dermatologic disorders, except for folliculitis and acne
•On therapy with steroids
•On therapy with a drug that would affect collagen synthesis
•Positive urine test for nicotine or drugs of abuse
•Positive blood test for HIV 1 or 2, hepatitis B or hepatitis C
•Positive blood test for anti-AZX100 antibodies
+9 more criteria

Locations (3)

Lotus Clinical Research, Inc.

Pasadena, California, United States

Paddington Testing Company, Inc.

Philadelphia, Pennsylvania, United States

DermResearch, Inc.

Austin, Texas, United States

Key Dates

Start Date

May 1, 2009

Primary Completion Date

September 1, 2010

Completion Date

September 1, 2010

Last Updated

October 11, 2012

Enrollment

ACTUAL participants

Conditions

Scar PreventionScar Reduction

Interventions

AZX100 Drug Product

DRUG

Placebo

DRUG

AZX100 Drug Product

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

NCT00811577

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.

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

Inclusion Criteria

Exclusion Criteria

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

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

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