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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 scars that were made from trocars following arthroscopic shoulder surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AZX100-placebo | Experimental | Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive one low dose of AZX100 3 mg/linear cm, one high dose of AZX100 10 mg/linear cm, or placebo (saline). |
|
| Placebo-only | Placebo Comparator | Three trocar sites on each patient received one dose of placebo (saline). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Patients in the Placebo-only arm were dosed intradermally with placebo (saline) in three trocar sites on Day 9 (plus/minus 2 days) and Day 21 (plus/minus 2 days) after arthroscopic shoulder surgery. In the AZX100-placebo arm, 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations. |
| 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 and 3 mg AZX100, and placebo and 10 mg AZX100 12 months after shoulder surgery. Three trocar sites were randomized on each patient to receive AZX100 3 mg or AZX100 10 mg or placebo at 9 days and 21 days after shoulder surgery. PSAS results 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 results 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 Scores Rated by Independent Blinded Raters Using 3D Photography | Three trocar sites were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or saline placebo/cm at 9 days and 21 days after surgery. Twelve months after surgery, images of the trocar sites were longitudinally evaluated and rated using a standard 100 mm Visual Analog Scale (VAS) by two blinded independent dermatologists, with 0 being normal skin and 100 being the worst scar imaginable. 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 both 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 | ||
| Florida Research Associates |
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Enrollment in the study began in January 2009 and was completed in December 2009. All patients were enrolled in dermatological medical clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZX100-Placebo Arm | Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo. |
| FG001 | Placebo-only Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| AZX100 | Drug | AZX100 Drug Product 3 or 10 mg or placebo (saline) was administered intradermally at each of three trocar sites on each patient 9 ± 2 days and 21 ± 2 days after arthroscopic surgery. The three trocar sites (anterior, lateral, and posterior sides of the shoulder) were randomized to receive the same dose of study agent for both dose administrations. |
|
| 12 months |
| Between-group Mean Differences in Objective Measures Via 3D Photography (Elevation, Length, Width) | Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. 3D digital photography of each trocar scar was used to calculate scar length, width, minimum elevation, and maximum elevation in millimeters (mm) at 12 months. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smooth skin surface. This was always a negative number. Negative values (closer to zero) were more desirable. The maximum elevation value was the highest point of the scar above the interpolated smooth skin surface. A smaller value was preferred. | 12 months |
| Between-group Mean Differences in Objective Measures Via 3D Photography (Volume) | Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm, or AZX100 10 mg/cm, or placebo/cm at 9 days and 21 days following shoulder surgery. 3D digital photography of each trocar scar was used to calculate positive volume, negative volume, and total volume in millimeters cubed (mm^3) at 12 months. Positive volume included the scar volume that was calculated to be above the interpolated smooth skin surface. A smaller value was preferred. Negative volume included the volume of the scar calculated to be below the interpolated smooth skin surface. It was always a negative number; negative values (closer to zero) were more desirable. Total volume was calculated as the sum of positive volume and the absolute value of negative volume. Smaller values were more desirable. | 12 months |
| Histological Evaluation of Collagen | Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. A skin punch biopsy was taken of each trocar site at 12 months. The specimens were blindly scored in duplicate by a dermal pathologist for dermal collagen fiber density, maturity and orientation, where 0% was completely normal and 100% was completely abnormal. | 12 months |
| Histological Evaluation of Number of Alpha Smooth Muscle Actin Cells | Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. A skin punch biopsy was taken of each trocar site at 12 months. For exploratory purposes, the specimens were blindly scored in duplicate by a dermal pathologist for the estimated number of alpha-smooth muscle actin (α-SMA) positive cells per high powered field. Values ranged from 0 to several hundred. The number of α-SMA cells was assessed for exploratory purposes; therefore, at the time of this report, it was not known whether it was better to have a low or high α-SMA score. | 12 months |
| DeLand |
| Florida |
| 32720 |
| United States |
| Atlas Orthopedics & Sports Medicine | Orlando | Florida | 32822 | United States |
| Orthopaedics East, PA | Greenville | North Carolina | 27834 | United States |
| Texas Orthopedics, Sports & Rehab Assoc. | Austin | Texas | 78759 | United States |
Three trocar sites on each patient will receive one dose of placebo.
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AZX100-Placebo Arm | Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo. |
| BG001 | Placebo-only Arm | Three trocar sites on each patient will receive one dose of placebo. |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 and 3 mg AZX100, and placebo and 10 mg AZX100 12 months after shoulder surgery. Three trocar sites were randomized on each patient to receive AZX100 3 mg or AZX100 10 mg or placebo at 9 days and 21 days after shoulder surgery. PSAS results 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 results 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. | The efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including the patients receiving placebo-only). In the ITT sample for the POSAS outcomes, available sample sizes were 122 at Day 42 and 113 at Month 12 (including 4 subjects who withdrew from the study but were still followed for safety until Month 12). | Posted | Mean | Standard Deviation | Units on a scale | 12 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Between-group Mean Differences in Visual Analog Scale Scores Rated by Independent Blinded Raters Using 3D Photography | Three trocar sites were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or saline placebo/cm at 9 days and 21 days after surgery. Twelve months after surgery, images of the trocar sites were longitudinally evaluated and rated using a standard 100 mm Visual Analog Scale (VAS) by two blinded independent dermatologists, with 0 being normal skin and 100 being the worst scar imaginable. 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 both raters was not combined. | Efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the VAS outcome, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12). | Posted | Mean | Standard Deviation | Millimeters | 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Between-group Mean Differences in Objective Measures Via 3D Photography (Elevation, Length, Width) | Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. 3D digital photography of each trocar scar was used to calculate scar length, width, minimum elevation, and maximum elevation in millimeters (mm) at 12 months. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smooth skin surface. This was always a negative number. Negative values (closer to zero) were more desirable. The maximum elevation value was the highest point of the scar above the interpolated smooth skin surface. A smaller value was preferred. | Efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the scar objective measures, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12). | Posted | Mean | Standard Deviation | Millimeters | 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Between-group Mean Differences in Objective Measures Via 3D Photography (Volume) | Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm, or AZX100 10 mg/cm, or placebo/cm at 9 days and 21 days following shoulder surgery. 3D digital photography of each trocar scar was used to calculate positive volume, negative volume, and total volume in millimeters cubed (mm^3) at 12 months. Positive volume included the scar volume that was calculated to be above the interpolated smooth skin surface. A smaller value was preferred. Negative volume included the volume of the scar calculated to be below the interpolated smooth skin surface. It was always a negative number; negative values (closer to zero) were more desirable. Total volume was calculated as the sum of positive volume and the absolute value of negative volume. Smaller values were more desirable. | Efficacy analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the scar objective measures, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12). | Posted | Mean | Standard Deviation | Millimeters cubed | 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Histological Evaluation of Collagen | Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. A skin punch biopsy was taken of each trocar site at 12 months. The specimens were blindly scored in duplicate by a dermal pathologist for dermal collagen fiber density, maturity and orientation, where 0% was completely normal and 100% was completely abnormal. | This analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the histology analyses, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12). | Posted | Mean | Standard Deviation | Percent | 12 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Histological Evaluation of Number of Alpha Smooth Muscle Actin Cells | Three trocar sites designated as anterior, lateral and posterior were randomized on each patient to receive AZX100 3 mg/cm or AZX100 10 mg/cm or placebo/cm at 9 days and 21 days following shoulder surgery. A skin punch biopsy was taken of each trocar site at 12 months. For exploratory purposes, the specimens were blindly scored in duplicate by a dermal pathologist for the estimated number of alpha-smooth muscle actin (α-SMA) positive cells per high powered field. Values ranged from 0 to several hundred. The number of α-SMA cells was assessed for exploratory purposes; therefore, at the time of this report, it was not known whether it was better to have a low or high α-SMA score. | This analysis was based on patient data from the AZX100/Placebo cohort (i.e., not including patients receiving placebo-only). In the ITT sample for the histology analyses, available sample sizes were 122 at Day 42 and 113 at Month 12 (including four subjects who withdrew from the study but were still followed for safety until Month 12). | Posted | Mean | Standard Deviation | Cells per high-powered field | 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 a period of 24 months.
All 150 treated subjects were included in the adverse event analyses. Two groups were compared: 126 subjects who received placebo, 3 mg/cm, and 10 mg/cm of AZX100 at three shoulder trocar sites; and 24 subjects who received only placebo at three shoulder trocar sites.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZX100-Placebo Arm | Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo. | 8 | 126 | 125 | 126 | ||
| EG001 | Placebo-only Arm | Three trocar sites on each patient will receive one dose of placebo. | 2 | 24 | 21 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA (12.0) |
| ||
| Chest Pain | General disorders | MedDRA (12.0) |
| ||
| Cholecystitis, Acute | Hepatobiliary disorders | MedDRA (12.0) |
| ||
| Coronary Artery Occlusion | Cardiac disorders | MedDRA (12.0) |
| ||
| Hypertension | Vascular disorders | MedDRA (12.0) |
| ||
| Kyphosis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
| ||
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
| ||
| Myocardial Infarction | Cardiac disorders | MedDRA (12.0) |
| ||
| Nephrolithiasis | Renal and urinary disorders | MedDRA (12.0) |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
| ||
| Pseudarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
| ||
| Transient Ischemic Attack | Nervous system disorders | MedDRA (12.0) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
| ||
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA (12.0) |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
| ||
| Dizziness | Nervous system disorders | MedDRA (12.0) |
| ||
| Fatigue | General disorders | MedDRA (12.0) |
| ||
| Headache | Nervous system disorders | MedDRA (12.0) |
| ||
| Influenza | Infections and infestations | MedDRA (12.0) |
| ||
| Injection Site Erythema | General disorders | MedDRA (12.0) | Special note for injection site adverse events: There were three trocar treatment areas on the shoulder; therefore, a participant could have the same and/or different injection site events at all three trocar treatment sites simultaneously. |
| |
| Injection Site Irritation | General disorders | MedDRA (12.0) | Special note for injection site adverse events: There were three trocar treatment areas on the shoulder; therefore, a participant could have the same and/or different injection site events at all three trocar treatment sites simultaneously. |
| |
| Injection Site Pain | General disorders | MedDRA (12.0) | Special note for injection site adverse events: There were three trocar treatment areas on the shoulder; therefore, a participant could have the same and/or different injection site events at all three trocar treatment sites simultaneously. |
| |
| Injection Site Pruritus | General disorders | MedDRA (12.0) | Special note for injection site adverse events: There were three trocar treatment areas on the shoulder; therefore, a participant could have the same and/or different injection site events at all three trocar treatment sites simultaneously. |
| |
| Injection Site Urticaria | General disorders | MedDRA (12.0) | Special note for injection site adverse events: There were three trocar treatment areas on the shoulder; therefore, a participant could have the same and/or different injection site events at all three trocar treatment sites simultaneously. |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA (12.0) |
| ||
| Nausea | Gastrointestinal disorders | MedDRA (12.0) |
| ||
| Oedema Peripheral | General disorders | MedDRA (12.0) |
| ||
| Sinusitis | Infections and infestations | MedDRA (12.0) |
| ||
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (12.0) |
| ||
| Vomiting | Gastrointestinal disorders | MedDRA (12.0) |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Denise Lamon | Capstone Therapeutics Corp. | 602-286-5206 | dlamon@capstonethx.com |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C539010 | AZX 100 |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates. | Wilcoxon (signed rank) | 0.56 | For this early phase study, multiple comparisons adjustments were not used. | 95 | No | Superiority or Other |
| Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates. | Wilcoxon (signed rank) | 0.61 | For this early phase study, multiple comparisons adjustments were not used. | 95 | No | Superiority or Other |
| Using serial gate-keeping to preserve the 5% overall type I error of 1-4 two-sided tests, 2-sided Wilcoxon Signed Rank tests were used. Computer graphics were used to display outcomes at Month 12, compare paired differences of outcomes between the 2 dosages and placebo, and show time trends in mean outcomes. Repeated measures regression models (GEE models in SAS/STAT PROC GENMOD) were used to examine longitudinal outcomes with terms for treatment and trocar location adjusted for key covariates. | Wilcoxon (signed rank) | 0.80 | For this early phase study, multiple comparisons adjustments were not used. | 95 | No | Superiority or Other |
| OG002 | Rater 1 VAS Scores for 10 mg AZX100 Trocar Scars | This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG003 | Rater 2 VAS Scores for Placebo Trocar Scars | This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery. |
| OG004 | Rater 2 VAS Scores for 3 mg AZX100 Trocar Scars | This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG005 | Rater 2 VAS Scores for 10 mg AZX100 Trocar Scars | This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery. |
|
|
|
This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG002 | Scar Length for 10 mg AZX100 Trocar Scars | This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG003 | Scar Width for Placebo Trocar Scars | This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery. |
| OG004 | Scar Width for 3 mg AZX100 Trocar Scars | This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG005 | Scar Width for 10 mg AZX100 Trocar Scars | This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG006 | Scar Minimum Elevation for Placebo Trocar Scars | This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 saline placebo/cm at 9 days and 21 days following shoulder surgery. |
| OG007 | Scar Minimum Elevation for 3 mg AZX100 Trocar Scars | This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG008 | Scar Minimum Elevation for 10 mg AZX100 Trocar Scars | This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG009 | Scar Maximum Elevation for Placebo Trocar Scars | This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery. |
| OG010 | Scar Maximum Elevation for 3 mg AZX100 Trocar Scars | This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG011 | Scar Maximum Elevation for 10 mg AZX100 Trocar Scars | This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery. |
|
|
|
| Scar Positive Volume for 3 mg AZX100 Trocar Scars |
This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG002 | Scar Positive Volume for 10 mg AZX100 Trocar Scars | This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG003 | Scar Negative Volume for Placebo Trocar Scars | This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery. |
| OG004 | Scar Negative Volume for 3 mg AZX100 Trocar Scars | This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG005 | Scar Negative Volume for 10 mg AZX100 Trocar Scars | This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG006 | Scar Total Volume for Placebo Trocar Scars | This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery. |
| OG007 | Scar Total Volume for 3 mg AZX100 Trocar Scars | This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG008 | Scar Total Volume for 10 mg AZX100 Trocar Scars | This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery. |
|
|
|
| OG002 | Collagen Fiber Density Results for 10 mg AZX100 Scars | This group included results for collagen fiber density at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG003 | Collagen Fiber Maturity Results for Placebo Scars | This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery. |
| OG004 | Collagen Fiber Maturity Results for 3 mg AZX100 Scars | This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG005 | Collagen Fiber Maturity Results for 10 mg AZX100 Scars | This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG006 | Collagen Fiber Orientation Results for Placebo Scars | This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery. |
| OG007 | Collagen Fiber Orientation Results for 3 mg AZX100 Scars | This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery. |
| OG008 | Collagen Fiber Orientation Results for 10 mg AZX100 Scars | This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery. |
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This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
| OG002 | Alpha SMA Results for 10 mg AZX100 Trocar Scars | This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery. |
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