A Phase 2 interventional study of AZX100 Drug Product and AZX100 Drug Product in Scar Prevention and Scar Reduction, sponsored by Capstone Therapeutics. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-10-11.
Sponsored by Capstone Therapeutics · Phase 2, Interventional, and Prevention
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.
123 studies on the registry are indexed under Keloid; 23 are open to participants now.
This study's enrollment of 59 is above the median of 30 across 97 interventional studies indexed under Keloid.
Browse Keloid studies →Capstone Therapeutics is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: AZX100 Drug Product
Drug: Placebo
Drug: AZX100 Drug Product
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 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.
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.
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.
Time frame: 12 Months
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 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.
Time frame: 12 months
Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)
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.
Time frame: 12 months
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 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.
Time frame: 12 months
Enrollment in the study began in April 2009 and was completed in August 2009. All patients were enrolled at dermatological medical clinics.
| Milestone | High Dose | Placebo | Low Dose |
|---|---|---|---|
| Started | 19 | 20 | 20 |
| Completed | 15 | 18 | 19 |
| Not completed | 4 | 2 | 1 |
| Withdrew: Lost to follow-up | 4 | 2 | 1 |
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.
| Units on a scale | PSAS Results for Placebo | PSAS Results for 3 mg AZX100 | PSAS Results for 10 mg AZX100 | OSAS Results for Placebo | OSAS Results for 3 mg AZX100 | OSAS Results for 10 mg AZX100 |
|---|---|---|---|---|---|---|
| Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores | 13.3 ± 13.8 | 17.7 ± 12.5 | 15.9 ± 11.3 | 17.1 ± 7.2 | 17.3 ± 8.6 | 15.5 ± 7.3 |
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.
| Millimeters | Rater 1 VAS Scores for Placebo | Rater 1 VAS Scores for 3 mg AZX100 | Rater 1 VAS Scores for 10 mg AZX100 | Rater 2 VAS Scores for Placebo | Rater 2 VAS Scores for 3 mg AZX100 | Rater 2 VAS Scores for 10 mg AZX100 |
|---|---|---|---|---|---|---|
| Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters | 62.3 ± 25.6 | 55.9 ± 30.3 | 54.9 ± 28.7 | 60.3 ± 11.8 | 57.2 ± 15.0 | 58.1 ± 16.3 |
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.
| Millimeters | Scar Length - Placebo | Scar Length - 3 mg AZX100 | Scar Length - 10 mg AZX100 | Scar Width - Placebo | Scar Width - 3 mg AZX100 | Scar Width - 10 mg AZX100 | Scar Minimum Elevation - Placebo | Scar Minimum Elevation - 3 mg AZX100 | Scar Minimum Elevation - 10 mg AZX100 | Scar Maximum Elevation - Placebo | Scar Maximum Elevation - 3 mg AZX100 | Scar Maximum Elevation - 10 mg AZX100 | Scar Mean Elevation - Placebo | Scar Mean Elevation - 3 mg AZX100 | Scar Mean Elevation - 10 mg AZX100 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width) | 26.8 ± 5.9 | 24.7 ± 5.6 | 27.2 ± 8.9 | 10.8 ± 4.2 | 13.3 ± 5.1 | 11.3 ± 4.5 | -0.5 ± 0.6 | -0.6 ± 0.6 | -0.5 ± 0.3 | 1.5 ± 1.0 | 1.7 ± 1.1 | 1.9 ± 1.4 | 0.3 ± 0.2 | 0.3 ± 0.3 | 0.3 ± 0.3 |
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.
| Millimeters cubed | Scar Positive Volume - Placebo | Scar Positive Volume - 3 mg AZX100 | Scar Positive Volume - 10 mg AZX100 | Scar Negative Volume - Placebo | Scar Negative Volume - 3 mg AZX100 | Scar Negative Volume - 10 mg AZX100 | Scar Total Volume - Placebo | Scar Total Volume - 3 mg AZX100 | Scar Total Volume - 10 mg AZX100 |
|---|---|---|---|---|---|---|---|---|---|
| Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume) | 0.3 ± 0.2 | 0.3 ± 0.4 | 0.5 ± 0.6 | -0.0 ± 0.0 | -0.0 ± 0.0 | -0.1 ± 0.1 | 0.3 ± 0.2 | 0.4 ± 0.4 | 0.6 ± 0.6 |
Collected over Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Dose | — | 0/19 (0%) | 16/19 (84.2%) |
| Placebo | — | 0/20 (0%) | 18/20 (90%) |
| Low Dose | — | 2/20 (10%) | 15/20 (75%) |
| Event | High Dose | Placebo | Low Dose |
|---|---|---|---|
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 0/19 | 0/20 | 1/20 |
| Transient Ischemic AttackCardiac disorders | 0/19 | 0/20 | 1/20 |
| Viral InfectionInfections and infestations | 0/19 | 0/20 | 1/20 |
| Event | High Dose | Placebo | Low Dose |
|---|---|---|---|
| Injecton site irritationGeneral disorders | 9/19 | 1/20 | 8/20 |
| Injection site painGeneral disorders | 8/19 | 7/20 | 7/20 |
| Injection site urticariaGeneral disorders | 8/19 | 4/20 | 6/20 |
| Injection site erythemaGeneral disorders | 6/19 | 1/20 | 6/20 |
| HeadacheNervous system disorders | 3/19 | 6/20 | 6/20 |
| Injection site reactionGeneral disorders | 5/19 | 0/20 | 2/20 |
| Upper respiratory infectionInfections and infestations | 1/19 | 1/20 | 5/20 |
| NasopharyngitisInfections and infestations | 2/19 | 3/20 | 4/20 |
| Injection site pruritusGeneral disorders | 3/19 | 3/20 | 3/20 |
| Back painMusculoskeletal and connective tissue disorders | 1/19 | 3/20 | 2/20 |
| Age, Categorical(Participants) | High Dose | Placebo | Low Dose | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 19 | 20 | 20 | 59 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age Continuous(years) | High Dose | Placebo | Low Dose | Total |
|---|---|---|---|---|
| Mean | 38.2 ± 11.1 | 37.5 ± 11.7 | 38.2 ± 11.1 | 37.9 ± 11.3 |
| Sex: Female, Male(Participants) | High Dose | Placebo | Low Dose | Total |
|---|---|---|---|---|
| Female | 5 | 7 | 3 | 15 |
| Male | 14 | 13 | 17 | 44 |
| Region of Enrollment(participants) | High Dose | Placebo | Low Dose | Total |
|---|---|---|---|---|
| United States | 19 | 20 | 20 | 59 |
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