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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Capstone Therapeutics
ClinicalTrials.gov Identifier:
NCT00892723
First received: April 30, 2009
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

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.


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 Additional Doses of AZX100 Drug Product Following Excision of Keloids

Resource links provided by NLM:


Further study details as provided by Capstone Therapeutics:

Primary Outcome Measures:
  • Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 59
Study Start Date: May 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Dose Drug: AZX100 Drug Product
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.
Experimental: High Dose Drug: AZX100 Drug Product
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.
Placebo Comparator: Placebo Drug: Placebo
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892723

Locations
United States, California
Lotus Clinical Research, Inc.
Pasadena, California, United States, 91105
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: Capstone Therapeutics
ClinicalTrials.gov Identifier: NCT00892723     History of Changes
Other Study ID Numbers: OL-ASCAR-05
Study First Received: April 30, 2009
Results First Received: May 17, 2012
Last Updated: September 10, 2012
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:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014