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COMPLETEDPHASE2

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

NCT00825916•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 between 1 and 3 cm long, less than 1 cm at its widest point
•willing to undergo keloid scar removal 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 malignant neoplasm within the last 5 years, except for surgically removed cancers of the skin that are not on the keloid area
•history of anaphylactic shock or anaphylactoid (hypersensitivity) reaction
•allergy to local anesthesia, including lidocaine and epinephrine
•ongoing 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 (2)

Paddington Testing Company, Inc.

Philadelphia, Pennsylvania, United States

DermResearch, Inc.

Austin, Texas, United States

Key Dates

Start Date

March 1, 2009

Primary Completion Date

July 1, 2010

Completion Date

July 1, 2010

Last Updated

October 11, 2012

Enrollment

ACTUAL participants

Conditions

Scar PreventionScar Reduction

Interventions

AZX100 Drug Product

DRUG

AZX100 Drug Product

DRUG

Placebo

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 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 Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars