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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 |
|---|---|---|---|
| Low Dose | Experimental |
| |
| High Dose | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZX100 Drug Product | Drug | 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. |
| 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, 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. | 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 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Research, Inc. | Pasadena | California | 91105 | United States | ||
| Paddington Testing Company, Inc. |
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Enrollment in the study began in June 2009 and was completed in September 2010. All patients were enrolled in dermatological medical clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose | AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
| FG001 | High Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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. |
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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. |
|
| 12 Months |
| 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. | 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 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. | 12 months |
| Philadelphia |
| Pennsylvania |
| 19103 |
| United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
| FG002 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose | AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
| BG001 | High Dose | AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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, 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. | 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 |
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| 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 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. | 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 |
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| Secondary | 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. | 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 |
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| 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 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. | 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 |
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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 a period of 15 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 | Low Dose | AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery. | 0 | 21 | 18 | 21 | ||
| EG001 | High Dose | AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery. | 0 | 19 | 17 | 19 | ||
| EG002 | 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 | 19 | 18 | 19 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
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| Diarrhea | Gastrointestinal disorders | MedDRA (12.0) |
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| Headache | Nervous system disorders | MedDRA (12.0) |
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| Hypersensitivity | Immune system disorders | MedDRA (12.0) |
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| Injection Site Erythema | General disorders | MedDRA (12.0) |
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| Injection Site Irritation | General disorders | MedDRA (12.0) |
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| Injection Site Pain | General disorders | MedDRA 12.0 |
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| Injection Site Pruritus | General disorders | MedDRA (12.0) |
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| Injection Site Reaction | General disorders | MedDRA (12.0) |
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| Injection Site Urticaria | General disorders | MedDRA (12.0) |
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| Nasopharyngitis | Infections and infestations | MedDRA (12.0) |
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| Nausea | Gastrointestinal disorders | MedDRA (12.0) |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (12.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Denise Lamon | Capstone Therapeutics | 800-937-5520 | 5206 | dlamon@capstonethx.com |
| ID | Term |
|---|---|
| D007627 | Keloid |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| 0.86 |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (rank sum) | For this early phase study, no adjustment was used. | 0.11 | 95 | No | Superiority or Other |
| Wilcoxon (rank sum) | For this early phase study, no adjustment was used. | 0.91 | 95 | No | Superiority or Other |
| Rater 1 VAS Scores for 1 mg AZX100 |
This group included Month 12 VAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
| OG003 | Rater 2 VAS Scores for Placebo | This group included Month 12 VAS scores for those 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 | Rater 2 VAS Scores for 0.3 mg AZX100 | This group included Month 12 VAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
| OG005 | Rater 2 VAS Scores for 1 mg AZX100 | This group included Month 12 VAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery. |
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| OG001 |
| Scar Length - 0.3 mg AZX100 |
This group included Month 12 scar length measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG002 | Scar Length - 1 mg AZX100 | This group included Month 12 scar length measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG003 | Scar Width - Placebo | This group included Month 12 scar width measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG004 | Scar Width - 0.3 mg AZX100 | This group included Month 12 scar width measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG005 | Scar Width - 1 mg AZX100 | This group included Month 12 scar width measurements (mm)for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG006 | Scar Minimum Elevation - Placebo | This group included Month 12 scar minimum elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG007 | Scar Minimum Elevation - 0.3 mg AZX100 | This group included Month 12 scar minimum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG008 | Scar Minimum Elevation - 1 mg AZX100 | This group included Month 12 scar minimum elevation measurements f(mm) or those patients who received 1 mg/ AZX100linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG009 | Scar Maximum Elevation - Placebo | This group included Month 12 scar maximum elevation measurements f(mm) or those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG010 | Scar Maximum Elevation - 0.3 mg AZX100 | This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG011 | Scar Maximum Elevation - 1 mg AZX100 | This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG012 | Scar Mean Elevation - Placebo | This group included Month 12 scar mean elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG013 | Scar Mean Elevation - 0.3 mg AZX100 | This group included Month 12 scar mean elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG014 | Scar Mean Elevation - 1 mg AZX100 | This group included Month 12 scar mean elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
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| OG002 | Scar Positive Volume - 1 mg AZX100 | This group included Month 12 scar positive volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG003 | Scar Negative Volume - Placebo | This group included Month 12 scar negative volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG004 | Scar Negative Volume - 0.3 mg AZX100 | This group included Month 12 scar negative volume measurements (mm^3) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG005 | Scar Negative Volume - 1 mg AZX100 | This group included Month 12 scar negative volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG006 | Scar Total Volume - Placebo | This group included Month 12 scar total volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG007 | Scar Total Volume - 0.3 mg AZX100 | This group included Month 12 scar total volume measurements (mm^3) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
| OG008 | Scar Total Volume - 1 mg AZX100 | This group included Month 12 scar total volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery. |
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