Back to resultsA Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars
Primary Purpose
Scar Prevention, Scar Reduction
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AZX100 Drug Product
Placebo
AZX100 Drug Product
Sponsored by
About this trial
This is an interventional prevention trial for Scar Prevention focused on measuring AZX100, Patient and Observer Scar Assessment Scale, POSAS, Visual Analog Scale, VAS, Keloid, Scarring, Scar reduction, Scar prevention
Eligibility Criteria
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
- Participation in another study within 60 days prior to enrollment
- Blood donation within 7 days before dosing with study drug
- Plasma donation within 3 days before dosing with study drug
- Tattoo within approximately 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 of a tanning bed or tanning light within the 3 months before enrollment
- Intend to use any scar improving product during of the study (1 year)
- History of drug addiction or excessive use of alcohol
- Previous drug treatment of the keloid scar within the last 3 years, or have had any laser, irradiation, or surgical treatment of the keloid scar that will be removed
Sites / Locations
- Lotus Clinical Research, Inc.
- Paddington Testing Company, Inc.
- DermResearch, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Low Dose
High Dose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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, 0.3 mg AZX100, and 1 mg AZX100 12 months after surgery. This gave four comparisons to placebo: patient or observer and 0.3 mg and 1 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.
Secondary Outcome Measures
Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters
At 12 months, two independent dermatologists who were blinded to study treatment evaluated the scar images using a Visual Analog Scale (VAS) of 0-100 mm, with 0 being normal skin and 100 being the worst scar imaginable. The scars were presented in a scrambled order. Efficacy was based on the difference between VAS scores of placebo and 0.3 mg AZX100, and placebo and 1 mg AZX100, for each of the two raters separately. Data from the two raters was not combined.
Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)
This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included maximum length, maximum width perpendicular to the maximum length, and minimum, maximum and mean elevation. All elevation measurements were made relative to the interpolated smooth skin surface. A value closest to zero was preferred, because zero was equal to the normal skin surface. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smoooth skin surface and was always a negative number. A more negative number was worse, because it indicated a deeper measurement below the interpolated smooth skin surface. The maximum elevation value was calculated as the highest point of the scar above the interpolated smooth skin surface. A larger number was worse because it indicated a higher peak above the interpolated smooth skin surface. The mean elevation of the scar relative to the interpolated smooth skin surface was also calculated.
Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)
This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included positive volume, negative volume and total volume. All volume measurements were made relative to the interpolated smooth skin surface. A value closer to zero was preferred, because zero was equal to the normal skin surface. Positive volume was calculated as the volume of the scar above the interpolated smooth skin surface. Negative volume was calculated as the volume of the scar below the interpolated smooth skin surface, and was always a negative number. Total volume was calculated as the sum of the positive volume and the absolute value of the negative volume.
Full Information
NCT ID
NCT00892723
First Posted
April 30, 2009
Last Updated
September 10, 2012
Sponsor
Capstone Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT00892723
Brief Title
A Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Capstone Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scar Prevention, Scar Reduction
Keywords
AZX100, Patient and Observer Scar Assessment Scale, POSAS, Visual Analog Scale, VAS, Keloid, Scarring, Scar reduction, Scar prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Dose
Arm Type
Experimental
Arm Title
High Dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
AZX100 Drug Product
Intervention Description
Subjects were administered AZX100 0.3 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
AZX100 Drug Product
Intervention Description
Subjects were administered AZX100 10 mg per linear centimeter (high 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.
Primary Outcome Measure Information:
Title
Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores
Description
Efficacy was based on the difference between mean POSAS scores of placebo, 0.3 mg AZX100, and 1 mg AZX100 12 months after surgery. This gave four comparisons to placebo: patient or observer and 0.3 mg and 1 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.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters
Description
At 12 months, two independent dermatologists who were blinded to study treatment evaluated the scar images using a Visual Analog Scale (VAS) of 0-100 mm, with 0 being normal skin and 100 being the worst scar imaginable. The scars were presented in a scrambled order. Efficacy was based on the difference between VAS scores of placebo and 0.3 mg AZX100, and placebo and 1 mg AZX100, for each of the two raters separately. Data from the two raters was not combined.
Time Frame
12 Months
Title
Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)
Description
This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included maximum length, maximum width perpendicular to the maximum length, and minimum, maximum and mean elevation. All elevation measurements were made relative to the interpolated smooth skin surface. A value closest to zero was preferred, because zero was equal to the normal skin surface. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smoooth skin surface and was always a negative number. A more negative number was worse, because it indicated a deeper measurement below the interpolated smooth skin surface. The maximum elevation value was calculated as the highest point of the scar above the interpolated smooth skin surface. A larger number was worse because it indicated a higher peak above the interpolated smooth skin surface. The mean elevation of the scar relative to the interpolated smooth skin surface was also calculated.
Time Frame
12 Months
Title
Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)
Description
This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included positive volume, negative volume and total volume. All volume measurements were made relative to the interpolated smooth skin surface. A value closer to zero was preferred, because zero was equal to the normal skin surface. Positive volume was calculated as the volume of the scar above the interpolated smooth skin surface. Negative volume was calculated as the volume of the scar below the interpolated smooth skin surface, and was always a negative number. Total volume was calculated as the sum of the positive volume and the absolute value of the negative volume.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Participation in another study within 60 days prior to enrollment
Blood donation within 7 days before dosing with study drug
Plasma donation within 3 days before dosing with study drug
Tattoo within approximately 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 of a tanning bed or tanning light within the 3 months before enrollment
Intend to use any scar improving product during of the study (1 year)
History of drug addiction or excessive use of alcohol
Previous drug treatment of the keloid scar within the last 3 years, or have had any laser, irradiation, or surgical treatment of the keloid scar that will be removed
Facility Information:
Facility Name
Lotus Clinical Research, Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Paddington Testing Company, Inc.
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of Additional Doses of AZX100 Drug Product Following Excision of Keloid Scars
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