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

Sponsor:	Capstone Therapeutics
Information provided by:	Capstone Therapeutics
ClinicalTrials.gov Identifier:	NCT00825916

Purpose

The purpose of this study is to determine the safety of AZX100 Drug Product and to determine whether it is effective in preventing or reducing re-growth of surgically removed keloid scars.

Condition	Intervention	Phase
Scar Prevention Scar Reduction	Drug: AZX100 Drug Product Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Scars

U.S. FDA Resources

Further study details as provided by Capstone Therapeutics:

Primary Outcome Measures:

Differences among the three dosage groups in the Patient and Observer Scar Assessment Scale (POSAS) scores [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Between-group mean differences in Visual Analog Scale scores by independent blinded raters based on 2D images [ Time Frame: 6 weeks through 12 months ] [ Designated as safety issue: No ]
Between-group mean differences in Patient and Observer Scar Assessment Scale scores [ Time Frame: 6 weeks through 12 months ] [ Designated as safety issue: No ]
Between-group mean differences in objective measures obtained via 3D photography [ Time Frame: 6 weeks through 12 months ] [ Designated as safety issue: No ]
Analysis of adverse events, vital signs, and clinical laboratory parameters [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Enrollment:	60
Study Start Date:	March 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: High Dose	Drug: AZX100 Drug Product Subjects will be administered AZX100 10 mg per linear centimeter (high dose) intradermally at the site of the keloid scar removal. The first dose will be given 19-23 days following surgery, and the second dose will be given 40-44 days following surgery.
Placebo Comparator: Placebo	Drug: Placebo Subjects will be administered placebo (0.9% saline) per linear centimeter intradermally at the site of the keloid scar removal. The first dose will be given 19-23 days following surgery, and the second dose will be given 40-44 days following surgery.
Experimental: Low Dose	Drug: AZX100 Drug Product Subjects will be administered AZX100 3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal. The first dose will be given 19-23 days following surgery, and the second dose will be given 40-44 days following surgery.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
participation in another study within 60 days prior to enrollment
donate blood within 7 days before dosing with study drug
donate plasma within 3 days before dosing with study drug
have a tattoo within 3 cm of the keloid scar that will be removed
apply any lotion or cream on or near the keloid scar that will be removed within 14 days before dosing with study drug
use a tanning bed or tanning light within 3 months before enrollment
intend to use any scar improving product during the study (one year)
history of drug addiction or excessive use of alcohol
previous drug treatment of the keloid scar that will be removed within the last 3 years; any laser, irradiation, or surgery of the keloid scar that will be removed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825916

Locations

United States, Pennsylvania
Paddington Testing Company, Inc.
Philadelphia, Pennsylvania, United States, 19103
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759

Sponsors and Collaborators

Capstone Therapeutics

More Information

No publications provided

Responsible Party:	Denise Lamon, Director Regulatory Affairs, Capstone Therapeutics
ClinicalTrials.gov Identifier:	NCT00825916 History of Changes
Other Study ID Numbers:	OL-ASCAR-04
Study First Received:	January 20, 2009
Last Updated:	August 18, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Capstone Therapeutics:

AZX100
Patient and Observer Scar Assessment Scale
POSAS
Visual Analog Scale
VAS

Keloid
Scarring
Scar reduction
Scar prevention

Additional relevant MeSH terms:

Keloid
Cicatrix
Collagen Diseases

Connective Tissue Diseases
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 24, 2012