Trial Outcomes & Findings for A Phase 2a Study to Evaluate the Safety and Efficacy of AZX100 in Trocar Sites of Arthroscopic Shoulder Surgery Patients (NCT NCT00811577)

Last Updated: 2012-10-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

150 participants

Primary outcome timeframe

12 months

Results posted on

2012-10-11

Participant Flow

Enrollment in the study began in January 2009 and was completed in December 2009. All patients were enrolled in dermatological medical clinics.

Participant milestones

Participant milestones
Measure	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.	Placebo-only Arm Three trocar sites on each patient will receive one dose of placebo.
Overall Study STARTED	126	24
Overall Study COMPLETED	116	23
Overall Study NOT COMPLETED	10	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Placebo-only Arm Three trocar sites on each patient will receive one dose of placebo.
Overall Study Lost to Follow-up	7	1
Overall Study Withdrawal by Subject	3	0

Baseline Characteristics

A Phase 2a Study to Evaluate the Safety and Efficacy of AZX100 in Trocar Sites of Arthroscopic Shoulder Surgery Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZX100-Placebo Arm n=126 Participants 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.	Placebo-only Arm n=24 Participants Three trocar sites on each patient will receive one dose of placebo.	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	112 Participants n=5 Participants	19 Participants n=7 Participants	131 Participants n=5 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	5 Participants n=7 Participants	19 Participants n=5 Participants
Age Continuous	51.3 years STANDARD_DEVIATION 11.8 • n=5 Participants	51.8 years STANDARD_DEVIATION 13.2 • n=7 Participants	51.4 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	7 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	90 Participants n=5 Participants	17 Participants n=7 Participants	107 Participants n=5 Participants
Region of Enrollment United States	126 participants n=5 Participants	24 participants n=7 Participants	150 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 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).

Outcome measures

Outcome measures
Measure	PSAS Results for Placebo Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.	PSAS Results for 3 mg AZX100 Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.	PSAS Results for 10 mg AZX100 Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for Placebo Trocar Scars n=113 Participants This group included OSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for 3 mg AZX100 Trocar Scars n=113 Participants This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for 10 mg AZX100 Trocar Scars n=113 Participants This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.	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.	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.	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.	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.	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.	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.
Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores	8.0 Units on a scale Standard Deviation 4.1	8.0 Units on a scale Standard Deviation 4.7	8.3 Units on a scale Standard Deviation 5.0	6.8 Units on a scale Standard Deviation 2.7	6.8 Units on a scale Standard Deviation 2.5	6.9 Units on a scale Standard Deviation 2.5	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months

Population: 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).

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.

Outcome measures

Outcome measures
Measure	PSAS Results for Placebo Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.	PSAS Results for 3 mg AZX100 Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.	PSAS Results for 10 mg AZX100 Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for Placebo Trocar Scars n=113 Participants This group included OSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for 3 mg AZX100 Trocar Scars n=113 Participants This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for 10 mg AZX100 Trocar Scars n=113 Participants This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.	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.	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.	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.	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.	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.	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.
Between-group Mean Differences in Visual Analog Scale Scores Rated by Independent Blinded Raters Using 3D Photography	10.96 Millimeters Standard Deviation 8.58	11.78 Millimeters Standard Deviation 9.91	11.86 Millimeters Standard Deviation 7.21	17.23 Millimeters Standard Deviation 12.25	17.49 Millimeters Standard Deviation 11.66	18.49 Millimeters Standard Deviation 11.20	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months

Population: 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).

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.

Outcome measures

Outcome measures
Measure	PSAS Results for Placebo Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.	PSAS Results for 3 mg AZX100 Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.	PSAS Results for 10 mg AZX100 Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for Placebo Trocar Scars n=113 Participants This group included OSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for 3 mg AZX100 Trocar Scars n=113 Participants This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for 10 mg AZX100 Trocar Scars n=113 Participants This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.	Scar Minimum Elevation for Placebo Trocar Scars n=113 Participants 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.	Scar Minimum Elevation for 3 mg AZX100 Trocar Scars n=113 Participants 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.	Scar Minimum Elevation for 10 mg AZX100 Trocar Scars n=113 Participants 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.	Scar Maximum Elevation for Placebo Trocar Scars n=113 Participants 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.	Scar Maximum Elevation for 3 mg AZX100 Trocar Scars n=113 Participants 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.	Scar Maximum Elevation for 10 mg AZX100 Trocar Scars n=113 Participants 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.
Between-group Mean Differences in Objective Measures Via 3D Photography (Elevation, Length, Width)	8.75 Millimeters Standard Deviation 4.12	8.74 Millimeters Standard Deviation 3.70	9.59 Millimeters Standard Deviation 3.84	2.62 Millimeters Standard Deviation 1.50	2.59 Millimeters Standard Deviation 1.31	2.71 Millimeters Standard Deviation 1.35	-0.26 Millimeters Standard Deviation 0.19	-0.29 Millimeters Standard Deviation 0.21	-0.27 Millimeters Standard Deviation 0.20	0.19 Millimeters Standard Deviation 0.17	0.18 Millimeters Standard Deviation 0.13	0.19 Millimeters Standard Deviation 0.13

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	PSAS Results for Placebo Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.	PSAS Results for 3 mg AZX100 Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.	PSAS Results for 10 mg AZX100 Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for Placebo Trocar Scars n=113 Participants This group included OSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for 3 mg AZX100 Trocar Scars n=113 Participants This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for 10 mg AZX100 Trocar Scars n=113 Participants This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.	Scar Minimum Elevation for Placebo Trocar Scars n=113 Participants 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.	Scar Minimum Elevation for 3 mg AZX100 Trocar Scars n=113 Participants 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.	Scar Minimum Elevation for 10 mg AZX100 Trocar Scars n=113 Participants 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.	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.	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.	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.
Between-group Mean Differences in Objective Measures Via 3D Photography (Volume)	4.74 Millimeters cubed Standard Deviation 8.95	4.05 Millimeters cubed Standard Deviation 4.25	4.44 Millimeters cubed Standard Deviation 4.46	-8.42 Millimeters cubed Standard Deviation 8.66	-9.44 Millimeters cubed Standard Deviation 12.77	-9.59 Millimeters cubed Standard Deviation 13.01	13.16 Millimeters cubed Standard Deviation 11.53	13.49 Millimeters cubed Standard Deviation 13.36	14.03 Millimeters cubed Standard Deviation 13.68	—	—	—

SECONDARY outcome

Timeframe: 12 months

Population: 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).

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.

Outcome measures

Outcome measures
Measure	PSAS Results for Placebo Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.	PSAS Results for 3 mg AZX100 Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.	PSAS Results for 10 mg AZX100 Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for Placebo Trocar Scars n=113 Participants This group included OSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for 3 mg AZX100 Trocar Scars n=113 Participants This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for 10 mg AZX100 Trocar Scars n=113 Participants This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.	Scar Minimum Elevation for Placebo Trocar Scars n=113 Participants 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.	Scar Minimum Elevation for 3 mg AZX100 Trocar Scars n=113 Participants 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.	Scar Minimum Elevation for 10 mg AZX100 Trocar Scars n=113 Participants 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.	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.	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.	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.
Histological Evaluation of Collagen	24.20 Percent Standard Deviation 24.08	19.43 Percent Standard Deviation 21.79	25.34 Percent Standard Deviation 23.18	22.72 Percent Standard Deviation 23.59	17.95 Percent Standard Deviation 21.52	23.64 Percent Standard Deviation 22.68	23.41 Percent Standard Deviation 24.54	18.52 Percent Standard Deviation 21.73	24.77 Percent Standard Deviation 24.00	—	—	—

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	PSAS Results for Placebo Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.	PSAS Results for 3 mg AZX100 Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.	PSAS Results for 10 mg AZX100 Trocar Scars n=113 Participants This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for Placebo Trocar Scars This group included OSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for 3 mg AZX100 Trocar Scars This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.	OSAS Results for 10 mg AZX100 Trocar Scars This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.	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.	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.	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.	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.	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.	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.
Histological Evaluation of Number of Alpha Smooth Muscle Actin Cells	22.07 Cells per high-powered field Standard Deviation 47.02	24.78 Cells per high-powered field Standard Deviation 58.25	32.80 Cells per high-powered field Standard Deviation 64.56	—	—	—	—	—	—	—	—	—

Adverse Events

AZX100-Placebo Arm

Serious events: 8 serious events

Other events: 125 other events

Deaths: 0 deaths

Placebo-only Arm

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AZX100-Placebo Arm n=126 participants at risk 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.	Placebo-only Arm n=24 participants at risk Three trocar sites on each patient will receive one dose of placebo.
Psychiatric disorders Anxiety	0.79% 1/126 • Number of events 1 • 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.	0.00% 0/24 • 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.
General disorders Chest Pain	0.79% 1/126 • Number of events 1 • 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.	4.2% 1/24 • Number of events 1 • 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.
Hepatobiliary disorders Cholecystitis, Acute	0.79% 1/126 • Number of events 1 • 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.	0.00% 0/24 • 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.
Cardiac disorders Coronary Artery Occlusion	0.79% 1/126 • Number of events 1 • 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.	0.00% 0/24 • 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.
Vascular disorders Hypertension	0.79% 1/126 • Number of events 1 • 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.	0.00% 0/24 • 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.
Musculoskeletal and connective tissue disorders Kyphosis	0.79% 1/126 • Number of events 1 • 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.	0.00% 0/24 • 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.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.79% 1/126 • Number of events 1 • 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.	4.2% 1/24 • Number of events 1 • 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.
Cardiac disorders Myocardial Infarction	0.79% 1/126 • Number of events 1 • 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.	0.00% 0/24 • 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.
Renal and urinary disorders Nephrolithiasis	0.79% 1/126 • Number of events 1 • 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.	0.00% 0/24 • 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.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.79% 1/126 • Number of events 1 • 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.	0.00% 0/24 • 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.
Musculoskeletal and connective tissue disorders Pseudarthrosis	0.79% 1/126 • Number of events 1 • 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.	0.00% 0/24 • 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.
Nervous system disorders Transient Ischemic Attack	0.79% 1/126 • Number of events 1 • 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.	0.00% 0/24 • 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.

Other adverse events

Additional Information

Denise Lamon

Capstone Therapeutics Corp.

Phone: 602-286-5206

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60