Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of AZX100 Drug Product Following Excision of Keloid Scars (NCT NCT00825916)

Last Updated: 2012-10-11

Results Overview

Efficacy was based on the difference between mean POSAS scores of placebo, 3 mg AZX100, and 10 mg AZX100 12 months after surgery. This gave four comparisons to placebo: patient or observer and 3 mg and 10 mg AZX100. PSAS included patients' ratings on a scale of 1-10 (1 was normal skin or no complaints and 10 was the worst imaginable scar or the worst difference) for the following: Is the scar painful? Is the scar itching? Is the color of the scar different? Is the scar more stiff? Is the thickness of the scar different? Is the scar irregular? The possible minimum score was 6 and the maximum (worst) score was 60. OSAS included observers' ratings on a scale of 1-10 (1 was normal skin and 10 was the worst scar imaginable) for vascularization, pigmentation, thickness, relief, and pliability. The possible minimum score was 5 and the possible maximum (worst) score was 50.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

59 participants

Primary outcome timeframe

12 Months

Results posted on

2012-10-11

Participant Flow

Enrollment in the study began in April 2009 and was completed in August 2009. All patients were enrolled at dermatological medical clinics.

Participant milestones

Participant milestones
Measure	High Dose AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.	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.	Low Dose AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
Overall Study STARTED	19	20	20
Overall Study COMPLETED	15	18	19
Overall Study NOT COMPLETED	4	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	High Dose AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.	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.	Low Dose AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
Overall Study Lost to Follow-up	4	2	1

Baseline Characteristics

A Study to Evaluate the Safety and Efficacy of AZX100 Drug Product Following Excision of Keloid Scars

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Dose n=19 Participants AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Placebo n=20 Participants 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.	Low Dose n=20 Participants AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Total n=59 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	20 Participants n=7 Participants	20 Participants n=5 Participants	59 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	38.2 years STANDARD_DEVIATION 11.1 • n=5 Participants	37.5 years STANDARD_DEVIATION 11.7 • n=7 Participants	38.2 years STANDARD_DEVIATION 11.1 • n=5 Participants	37.9 years STANDARD_DEVIATION 11.3 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	15 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	13 Participants n=7 Participants	17 Participants n=5 Participants	44 Participants n=4 Participants
Region of Enrollment United States	19 participants n=5 Participants	20 participants n=7 Participants	20 participants n=5 Participants	59 participants n=4 Participants

PRIMARY outcome

Timeframe: 12 Months

Population: 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.

Outcome measures

Outcome measures
Measure	PSAS Results for Placebo n=20 Participants This group included Month 12 PSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	PSAS Results for 3 mg AZX100 n=20 Participants This group included Month 12 PSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	PSAS Results for 10 mg AZX100 n=19 Participants This group included Month 12 PSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	OSAS Results for Placebo n=20 Participants This group included Month 12 OSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	OSAS Results for 3 mg AZX100 n=20 Participants This group included Month 12 OSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	OSAS Results for 10 mg AZX100 n=19 Participants This group included Month 12 OSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Minimum Elevation - Placebo This group included Month 12 scar minimum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Minimum Elevation - 3 mg AZX100 This group included Month 12 scar minimum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Minimum Elevation - 10 mg AZX100 This group included Month 12 scar minimum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Maximum Elevation - Placebo This group included Month 12 scar maximum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Maximum Elevation - 3 mg AZX100 This group included Month 12 scar maximum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Maximum Elevation - 10 mg AZX100 This group included Month 12 scar maximum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Mean Elevation - Placebo This group included Month 12 scar mean elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Mean Elevation - 3 mg AZX100 This group included Month 12 scar mean elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Mean Elevation - 10 mg AZX100 This group included Month 12 scar mean elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
Differences Among the 3 Dosage Groups in the Patient (PSAS) and Observer (OSAS) Scar Assessment Scale (POSAS) Scores	13.3 Units on a scale Standard Deviation 13.8	17.7 Units on a scale Standard Deviation 12.5	15.9 Units on a scale Standard Deviation 11.3	17.1 Units on a scale Standard Deviation 7.2	17.3 Units on a scale Standard Deviation 8.6	15.5 Units on a scale Standard Deviation 7.3	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months

At 12 months, two independent dermatologists who were blinded to study treatment evaluated the scar images using a Visual Analog Scale (VAS) of 0-100 millimeters (mm), with 0 being normal skin and 100 being the worst scar imaginable. The scars were presented in longitudinal (chronological) order. Efficacy was based on the difference between VAS scores of placebo and 3 mg AZX100, and placebo and 10 mg AZX100 for each of the two raters separately. Data from the two raters was not combined.

Outcome measures

Outcome measures
Measure	PSAS Results for Placebo n=20 Participants This group included Month 12 PSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	PSAS Results for 3 mg AZX100 n=20 Participants This group included Month 12 PSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	PSAS Results for 10 mg AZX100 n=19 Participants This group included Month 12 PSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	OSAS Results for Placebo n=20 Participants This group included Month 12 OSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	OSAS Results for 3 mg AZX100 n=20 Participants This group included Month 12 OSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	OSAS Results for 10 mg AZX100 n=19 Participants This group included Month 12 OSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Minimum Elevation - Placebo This group included Month 12 scar minimum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Minimum Elevation - 3 mg AZX100 This group included Month 12 scar minimum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Minimum Elevation - 10 mg AZX100 This group included Month 12 scar minimum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Maximum Elevation - Placebo This group included Month 12 scar maximum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Maximum Elevation - 3 mg AZX100 This group included Month 12 scar maximum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Maximum Elevation - 10 mg AZX100 This group included Month 12 scar maximum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Mean Elevation - Placebo This group included Month 12 scar mean elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Mean Elevation - 3 mg AZX100 This group included Month 12 scar mean elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Mean Elevation - 10 mg AZX100 This group included Month 12 scar mean elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
Between-group Mean Differences in Visual Analog Scale (VAS) Scores by Independent Blinded Raters	62.3 Millimeters Standard Deviation 25.6	55.9 Millimeters Standard Deviation 30.3	54.9 Millimeters Standard Deviation 28.7	60.3 Millimeters Standard Deviation 11.8	57.2 Millimeters Standard Deviation 15.0	58.1 Millimeters Standard Deviation 16.3	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months

This secondary outcome included scar measurements based on 3D photography of the scar surface at Month 12 and included maximum length, maximum width perpendicular to maximum length, and minimum, maximum and mean elevation. All elevation measurements were made relative to the interpolated smooth skin surface. A value closest to zero was preferred because zero was equal to the normal skin surface. The minimum elevation value was calculated as the lowest point of the scar below the interpolated smooth skin surface and was always a negative number. A more negative number was worse because it indicated a deeper measurement below the interpolated smooth skin surface. The maximum elevation value was calculated as the highest point of the scar above the interpolated smooth skin surface. A larger number was worse because it indicated a higher peak above the interpolated smooth skin surface. The mean elevation of the scar relative to the interpolated smooth skin surface was also calculated.

Outcome measures

Outcome measures
Measure	PSAS Results for Placebo n=20 Participants This group included Month 12 PSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	PSAS Results for 3 mg AZX100 n=20 Participants This group included Month 12 PSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	PSAS Results for 10 mg AZX100 n=19 Participants This group included Month 12 PSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	OSAS Results for Placebo n=20 Participants This group included Month 12 OSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	OSAS Results for 3 mg AZX100 n=20 Participants This group included Month 12 OSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	OSAS Results for 10 mg AZX100 n=19 Participants This group included Month 12 OSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Minimum Elevation - Placebo n=20 Participants This group included Month 12 scar minimum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Minimum Elevation - 3 mg AZX100 n=20 Participants This group included Month 12 scar minimum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Minimum Elevation - 10 mg AZX100 n=19 Participants This group included Month 12 scar minimum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Maximum Elevation - Placebo n=20 Participants This group included Month 12 scar maximum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Maximum Elevation - 3 mg AZX100 n=20 Participants This group included Month 12 scar maximum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Maximum Elevation - 10 mg AZX100 n=19 Participants This group included Month 12 scar maximum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Mean Elevation - Placebo n=20 Participants This group included Month 12 scar mean elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Mean Elevation - 3 mg AZX100 n=20 Participants This group included Month 12 scar mean elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Mean Elevation - 10 mg AZX100 n=19 Participants This group included Month 12 scar mean elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Elevation, Length, Width)	26.8 Millimeters Standard Deviation 5.9	24.7 Millimeters Standard Deviation 5.6	27.2 Millimeters Standard Deviation 8.9	10.8 Millimeters Standard Deviation 4.2	13.3 Millimeters Standard Deviation 5.1	11.3 Millimeters Standard Deviation 4.5	-0.5 Millimeters Standard Deviation 0.6	-0.6 Millimeters Standard Deviation 0.6	-0.5 Millimeters Standard Deviation 0.3	1.5 Millimeters Standard Deviation 1.0	1.7 Millimeters Standard Deviation 1.1	1.9 Millimeters Standard Deviation 1.4	0.3 Millimeters Standard Deviation 0.2	0.3 Millimeters Standard Deviation 0.3	0.3 Millimeters Standard Deviation 0.3

SECONDARY outcome

Timeframe: 12 months

This secondary outcome included measurements based on 3D photography of the scar surface at Month 12 and included positive volume, negative volume, and total volume. All volume measurements were made relative to the interpolated smooth skin surface. A value closer to zero was preferred, because zero was equal to the normal skin surface. Positive volume was calculated as the volume of the scar above the interpolated smooth skin surface. Negative volume was calculated as the volume of the scar below the smooth interpolated skin surface, and was always a negative number. Total volume was calculated as the sum of positive volume and the absolute value of negative volume. Smaller values were more desirable.

Outcome measures

Outcome measures
Measure	PSAS Results for Placebo n=20 Participants This group included Month 12 PSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	PSAS Results for 3 mg AZX100 n=20 Participants This group included Month 12 PSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	PSAS Results for 10 mg AZX100 n=19 Participants This group included Month 12 PSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	OSAS Results for Placebo n=20 Participants This group included Month 12 OSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	OSAS Results for 3 mg AZX100 n=20 Participants This group included Month 12 OSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	OSAS Results for 10 mg AZX100 n=19 Participants This group included Month 12 OSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Minimum Elevation - Placebo n=20 Participants This group included Month 12 scar minimum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Minimum Elevation - 3 mg AZX100 n=20 Participants This group included Month 12 scar minimum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Minimum Elevation - 10 mg AZX100 n=19 Participants This group included Month 12 scar minimum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Maximum Elevation - Placebo This group included Month 12 scar maximum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Maximum Elevation - 3 mg AZX100 This group included Month 12 scar maximum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Maximum Elevation - 10 mg AZX100 This group included Month 12 scar maximum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Mean Elevation - Placebo This group included Month 12 scar mean elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Mean Elevation - 3 mg AZX100 This group included Month 12 scar mean elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Scar Mean Elevation - 10 mg AZX100 This group included Month 12 scar mean elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
Between-group Mean Differences in Objective Measures Obtained Via 3D Photography (Volume)	0.3 Millimeters cubed Standard Deviation 0.2	0.3 Millimeters cubed Standard Deviation 0.4	0.5 Millimeters cubed Standard Deviation 0.6	-0.0 Millimeters cubed Standard Deviation 0.0	-0.0 Millimeters cubed Standard Deviation 0.0	-0.1 Millimeters cubed Standard Deviation 0.1	0.3 Millimeters cubed Standard Deviation 0.2	0.4 Millimeters cubed Standard Deviation 0.4	0.6 Millimeters cubed Standard Deviation 0.6	—	—	—	—	—	—

Adverse Events

High Dose

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Low Dose

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	High Dose n=19 participants at risk AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Placebo n=20 participants at risk 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.	Low Dose n=20 participants at risk AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/19 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	0.00% 0/20 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	5.0% 1/20 • 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 approximately 16 months.
Cardiac disorders Transient Ischemic Attack	0.00% 0/19 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	0.00% 0/20 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	5.0% 1/20 • 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 approximately 16 months.
Infections and infestations Viral Infection	0.00% 0/19 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	0.00% 0/20 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	5.0% 1/20 • 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 approximately 16 months.

Other adverse events

Additional Information

Denise Lamon, Director of Regulatory Affairs

Capstone Therapeutics

Phone: 800-937-5520

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	High Dose n=19 participants at risk AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.	Placebo n=20 participants at risk 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.	Low Dose n=20 participants at risk AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
Musculoskeletal and connective tissue disorders Back pain	5.3% 1/19 • 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 approximately 16 months.	15.0% 3/20 • Number of events 3 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	10.0% 2/20 • Number of events 2 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.
Infections and infestations Bronchitis	0.00% 0/19 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	10.0% 2/20 • Number of events 2 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	0.00% 0/20 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.
Nervous system disorders Headache	15.8% 3/19 • Number of events 7 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	30.0% 6/20 • Number of events 13 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	30.0% 6/20 • Number of events 11 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.
General disorders Injection site erythema	31.6% 6/19 • Number of events 8 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	5.0% 1/20 • 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 approximately 16 months.	30.0% 6/20 • Number of events 10 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.
General disorders Injection site induration	10.5% 2/19 • Number of events 2 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	0.00% 0/20 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	0.00% 0/20 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.
General disorders Injection site pain	42.1% 8/19 • Number of events 19 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	35.0% 7/20 • Number of events 12 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	35.0% 7/20 • Number of events 17 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.
General disorders Injection site pruritus	15.8% 3/19 • Number of events 4 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	15.0% 3/20 • Number of events 3 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	15.0% 3/20 • Number of events 3 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.
General disorders Injection site reaction	26.3% 5/19 • Number of events 7 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	0.00% 0/20 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	10.0% 2/20 • Number of events 3 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.
General disorders Injection site urticaria	42.1% 8/19 • Number of events 14 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	20.0% 4/20 • Number of events 5 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	30.0% 6/20 • Number of events 10 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.
General disorders Injecton site irritation	47.4% 9/19 • Number of events 17 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	5.0% 1/20 • Number of events 3 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	40.0% 8/20 • Number of events 18 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.
Infections and infestations Nasopharyngitis	10.5% 2/19 • Number of events 3 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	15.0% 3/20 • Number of events 3 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	20.0% 4/20 • Number of events 5 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.
Skin and subcutaneous tissue disorders Rash	10.5% 2/19 • Number of events 3 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	0.00% 0/20 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	0.00% 0/20 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.
Gastrointestinal disorders Stomach discomfort	0.00% 0/19 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	10.0% 2/20 • Number of events 2 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	0.00% 0/20 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.
Infections and infestations Upper respiratory infection	5.3% 1/19 • 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 approximately 16 months.	5.0% 1/20 • 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 approximately 16 months.	25.0% 5/20 • Number of events 5 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.
Infections and infestations Urninary tract infection	0.00% 0/19 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	0.00% 0/20 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.	10.0% 2/20 • Number of events 2 • Adverse events began to be collected for each patient after dosing with study agent, and were collected for the duration of the study (12 months) The adverse event collection period for the entire study lasted for approximately 16 months.