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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Dose | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Low Dose | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZX100 Drug Product | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paddington Testing Company, Inc. | Philadelphia | Pennsylvania | 19103 | United States | ||
| DermResearch, Inc. |
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Enrollment in the study began in April 2009 and was completed in August 2009. All patients were enrolled at dermatological medical clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose | AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
| FG001 | Placebo | Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
| FG002 | Low Dose | AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose | AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data. | Posted | Mean | Standard Deviation | Units on a scale | 12 Months |
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Dose | AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Denise Lamon, Director of Regulatory Affairs | Capstone Therapeutics | 800-937-5520 | 5206 | dlamon@capstonethx.com |
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| ID | Term |
|---|---|
| D007627 | Keloid |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005355 | Fibrosis |
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| AZX100 Drug Product | Drug | 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 | Drug | 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. |
|
| 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. | 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. | 12 months |
| Austin |
| Texas |
| 78759 |
| United States |
Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
| BG002 | Low Dose | AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | PSAS Results for Placebo | This group included Month 12 PSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
| OG001 | PSAS Results for 3 mg AZX100 | This group included Month 12 PSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
| OG002 | PSAS Results for 10 mg AZX100 | This group included Month 12 PSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
| OG003 | OSAS Results for Placebo | This group included Month 12 OSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
| OG004 | OSAS Results for 3 mg AZX100 | This group included Month 12 OSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
| OG005 | OSAS Results for 10 mg AZX100 | This group included Month 12 OSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
|
|
|
| Secondary | 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. | In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data. | Posted | Mean | Standard Deviation | Millimeters | 12 months |
|
|
|
|
| Secondary | 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. | In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data. | Posted | Mean | Standard Deviation | Millimeters | 12 months |
|
|
|
|
| Secondary | 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. | In this early phase study, the efficacy and safety analyses were performed using an evaluable subject sample, which included all subjects who received study agent and provided some efficacy or safety data. | Posted | Mean | Standard Deviation | Millimeters cubed | 12 months |
|
|
|
|
| 0 |
| 19 |
| 16 |
| 19 |
| EG001 | Placebo | Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery. | 0 | 20 | 18 | 20 |
| EG002 | Low Dose | AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery. | 2 | 20 | 15 | 20 |
| Transient Ischemic Attack | Cardiac disorders | MedDRA 12.0 |
|
| Viral Infection | Infections and infestations | MedDRA 12.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 12.0 |
|
| Headache | Nervous system disorders | MedDRA 12.0 |
|
| Injection site erythema | General disorders | MedDRA 12.0 |
|
| Injection site induration | General disorders | MedDRA 12.0 |
|
| Injection site pain | General disorders | MedDRA 12.0 |
|
| Injection site pruritus | General disorders | MedDRA 12.0 |
|
| Injection site reaction | General disorders | MedDRA 12.0 |
|
| Injection site urticaria | General disorders | MedDRA 12.0 |
|
| Injecton site irritation | General disorders | MedDRA 12.0 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 |
|
| Stomach discomfort | Gastrointestinal disorders | MedDRA 12.0 |
|
| Upper respiratory infection | Infections and infestations | MedDRA 12.0 |
|
| Urninary tract infection | Infections and infestations | MedDRA 12.0 |
|
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| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 0.59 |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (rank sum) | For this early phase study, no adjustment was used. | 0.69 | 95 | No | Superiority or Other |
| Wilcoxon (rank sum) | For this early phase study, no adjustment was used. | 1.00 | 95 | No | Superiority or Other |
| 0.98 |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (rank sum) | For this early phase study, no adjustment was used. | 0.15 | 95 | No | Superiority or Other |
| Wilcoxon (rank sum) | For this early phase study, no adjustment was used. | 0.83 | 95 | No | Superiority or Other |
| Wilcoxon (rank sum) | For this early phase study, no adjustment was used. | 0.95 | 95 | No | Superiority or Other |
| Wilcoxon (rank sum) | For this early phase study, no adjustment was used. | 0.59 | 95 | No | Superiority or Other |
| Wilcoxon (rank sum) | For this early phase study, no adjustment was used. | 0.76 | 95 | No | Superiority or Other |
| Wilcoxon (rank sum) | For this early phase study, no adjustment was used. | 0.63 | 95 | No | Superiority or Other |
| Wilcoxon (rank sum) | For this early phase study, no adjustment was used. | 0.92 | 95 | No | Superiority or Other |
| Wilcoxon (rank sum) | For this early phase study, no adjustment was used. | 0.69 | 95 | No | Superiority or Other |
| 0.76 |
For this early phase study, no adjustment was used. |
| 2-Sided |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (signed rank) | 0.60 | For this early phase study, no adjustment was used. | 2-Sided | 95 | No | Superiority or Other |
| Wilcoxon (signed rank) | 0.44 | For this early phase study, no adjustment was used. | 2-Sided | 95 | No | Superiority or Other |
| Wilcoxon (signed rank) | 0.85 | For this early phase study, no adjustment was used. | 2-Sided | 95 | No | Superiority or Other |
| Wilcoxon (signed rank) | 0.83 | For this early phase study, no adjustment was used. | 2-Sided | 95 | No | Superiority or Other |