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
1 other identifier
interventional
59
1 country
2
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 re-growth of surgically removed keloid scars.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2009
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2009
CompletedFirst Posted
Study publicly available on registry
January 21, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
October 11, 2012
CompletedOctober 11, 2012
September 1, 2012
1.3 years
January 20, 2009
May 17, 2012
September 10, 2012
Conditions
Keywords
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, 3 mg AZX100, and 10 mg AZX100 12 months after surgery. This gave four comparisons to placebo: patient or observer and 3 mg and 10 mg AZX100. PSAS 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 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 (3)
Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters
12 months
Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)
12 months
Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)
12 months
Study Arms (3)
High Dose
EXPERIMENTALPlacebo
PLACEBO COMPARATORLow Dose
EXPERIMENTALInterventions
Subjects were administered AZX100 3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
Subjects were administered placebo (0.9% saline) per linear centimeter intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Paddington Testing Company, Inc.
Philadelphia, Pennsylvania, 19103, United States
DermResearch, Inc.
Austin, Texas, 78759, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Denise Lamon, Director of Regulatory Affairs
- Organization
- Capstone Therapeutics
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
January 20, 2009
First Posted
January 21, 2009
Study Start
March 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
October 11, 2012
Results First Posted
October 11, 2012
Record last verified: 2012-09