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

Phase 2

Completed

Conditions: Scar Prevention
Scar Reduction

Interventions: Drug: AZX100 Drug Product
Drug: Placebo

Registration Number: NCT00825916

Lead Sponsor: Capstone Therapeutics

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 59

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose	AZX100 Drug Product	-
High Dose	AZX100 Drug Product	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores	12 Months	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.

Secondary Outcome Measures

Name	Time	Method
Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters	12 months	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 millimeters (mm), with 0 being normal skin and 100 being the worst scar imaginable. The scars were presented in longitudinal (chronological) order. Efficacy was based on the difference between VAS scores of placebo and 3 mg AZX100, and placebo and 10 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)	12 months	This secondary outcome included scar measurements based on 3D photography of the scar surface at Month 12 and included maximum length, maximum width perpendicular to 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 smooth 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)	12 months	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 smooth interpolated skin surface, and was always a negative number. Total volume was calculated as the sum of positive volume and the absolute value of negative volume. Smaller values were more desirable.