Trial Outcomes & Findings for A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus Deformity (NCT NCT03307837)

NCT ID: NCT03307837

Last Updated: 2021-06-30

Results Overview

Assessment of skin reactions to determine if any change from 24 to 48 hours.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 40 participants
• Primary outcome timeframe: 24 and 48 hours post infiltration
• Results posted on: 2021-06-30

Participant Flow

Of the 40 enrolled participants, all 40 met inclusion criteria and were randomized to treatment.

Participant milestones

Measure	CA-008 Cohort 1 0.5 mg Active (CA-008) to Placebo	CA-008 Cohort 2 1 mg Active (CA-008) to Placebo	CA-008 Cohort 3 2 mg Active (CA-008) to Placebo	CA-008 Cohort 4 3 mg Active (CA-008) to Placebo	CA-008 Cohort 5 4.2 mg Active (CA-008) to Placebo	Placebo Placebo
Overall Study STARTED	6	6	6	6	6	10
Overall Study COMPLETED	5	5	5	6	6	8
Overall Study NOT COMPLETED	1	1	1	0	0	2

Reasons for withdrawal

Measure	CA-008 Cohort 1 0.5 mg Active (CA-008) to Placebo	CA-008 Cohort 2 1 mg Active (CA-008) to Placebo	CA-008 Cohort 3 2 mg Active (CA-008) to Placebo	CA-008 Cohort 4 3 mg Active (CA-008) to Placebo	CA-008 Cohort 5 4.2 mg Active (CA-008) to Placebo	Placebo Placebo
Overall Study Withdrawal by Subject	0	0	1	0	0	1
Overall Study Lost to Follow-up	1	1	0	0	0	1

Baseline Characteristics

A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus Deformity

Baseline characteristics by cohort

Measure	CA-008 Cohort 1 0.5 mg n=6 Participants CA-008: The active moiety of CA-008, capsaicin that has certain properties for treatment of post-operative pain.	CA-008 Cohort 2 1 mg n=6 Participants CA-008: The active moiety of CA-008, capsaicin that has certain properties for treatment of post-operative pain.	CA-008 Cohort 3 2 mg n=6 Participants CA-008: The active moiety of CA-008, capsaicin that has certain properties for treatment of post-operative pain.	CA-008 Cohort 4 3 mg n=6 Participants CA-008: The active moiety of CA-008, capsaicin that has certain properties for treatment of post-operative pain.	CA-008 Cohort 5 4.2 mg n=6 Participants CA-008: The active moiety of CA-008, capsaicin that has certain properties for treatment of post-operative pain.	CA-008 Placebo n=10 Participants CA-008 Placebo: Placebo product	Total n=40 Participants Total of all reporting groups
Age, Continuous	34.5 years STANDARD_DEVIATION 12.94 • n=5 Participants	32.0 years STANDARD_DEVIATION 6.78 • n=7 Participants	40.3 years STANDARD_DEVIATION 12.52 • n=5 Participants	39.5 years STANDARD_DEVIATION 12.94 • n=4 Participants	34.3 years STANDARD_DEVIATION 10.25 • n=21 Participants	34.9 years STANDARD_DEVIATION 7.82 • n=10 Participants	35.8 years STANDARD_DEVIATION 10.2 • n=115 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	5 Participants n=21 Participants	8 Participants n=10 Participants	34 Participants n=115 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	6 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	14 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	8 Participants n=10 Participants	26 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants	15 Participants n=115 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=10 Participants	22 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants

PRIMARY outcome

Timeframe: 24 and 48 hours post infiltration

Population: Safety Population

Assessment of skin reactions to determine if any change from 24 to 48 hours.

Outcome measures

Measure	Cohort 1 n=6 Participants CA-008 in 0.5 mg dose	Cohort 2 n=6 Participants CA-008 in 1 mg dose	Cohort 3 n=6 Participants CA-008 in 2 mg dose	Cohort 4 n=6 Participants CA-008 in 3 mg dose	Cohort 5 n=6 Participants CA-008 in 4.2 mg dose	Placebo n=10 Participants Placebo administration
Surgical Site Assessment	0 Number of skin reactions	0 Number of skin reactions	0 Number of skin reactions	0 Number of skin reactions	0 Number of skin reactions	0 Number of skin reactions

PRIMARY outcome

Timeframe: 48 hours post infiltration

Population: Safety population

Change in neurosensory assessments of the skin surrounding the incision.

Outcome measures

Measure	Cohort 1 n=6 Participants CA-008 in 0.5 mg dose	Cohort 2 n=6 Participants CA-008 in 1 mg dose	Cohort 3 n=6 Participants CA-008 in 2 mg dose	Cohort 4 n=6 Participants CA-008 in 3 mg dose	Cohort 5 n=6 Participants CA-008 in 4.2 mg dose	Placebo n=10 Participants Placebo administration
Neurosensory Assessment	0 Number of neurosensory abnormalities	0 Number of neurosensory abnormalities	0 Number of neurosensory abnormalities	0 Number of neurosensory abnormalities	0 Number of neurosensory abnormalities	0 Number of neurosensory abnormalities

SECONDARY outcome

Timeframe: time 0 to Day 15

Pain as assessed by a standard 11-point (0-10) NPRS (with 10 as the worse outcome) Area under the curve (AUC)

Outcome measures

Measure	Cohort 1 n=6 Participants CA-008 in 0.5 mg dose	Cohort 2 n=6 Participants CA-008 in 1 mg dose	Cohort 3 n=6 Participants CA-008 in 2 mg dose	Cohort 4 n=6 Participants CA-008 in 3 mg dose	Cohort 5 n=6 Participants CA-008 in 4.2 mg dose	Placebo n=10 Participants Placebo administration
11-point (0-10) Numerical Pain Rating Scale (NPRS) AUC 0-12 hours	12.57 Scores on a scale*hours Standard Deviation 10.26	14.25 Scores on a scale*hours Standard Deviation 7.07	29.82 Scores on a scale*hours Standard Deviation 24.55	32.47 Scores on a scale*hours Standard Deviation 27.95	30.07 Scores on a scale*hours Standard Deviation 31.66	41.77 Scores on a scale*hours Standard Deviation 30.90
11-point (0-10) Numerical Pain Rating Scale (NPRS) AUC 12-24 hours	48.07 Scores on a scale*hours Standard Deviation 35.69	56.70 Scores on a scale*hours Standard Deviation 30.72	78.88 Scores on a scale*hours Standard Deviation 11.89	57.28 Scores on a scale*hours Standard Deviation 39.58	43.98 Scores on a scale*hours Standard Deviation 23.47	79.46 Scores on a scale*hours Standard Deviation 19.87
11-point (0-10) Numerical Pain Rating Scale (NPRS) AUC 24-72 hours	109.57 Scores on a scale*hours Standard Deviation 82.15	163.48 Scores on a scale*hours Standard Deviation 108.59	169.35 Scores on a scale*hours Standard Deviation 47.44	126.53 Scores on a scale*hours Standard Deviation 102.53	101.62 Scores on a scale*hours Standard Deviation 63.19	215.75 Scores on a scale*hours Standard Deviation 93.95
11-point (0-10) Numerical Pain Rating Scale (NPRS) AUC 24-96 hours	169.08 Scores on a scale*hours Standard Deviation 132.37	267.47 Scores on a scale*hours Standard Deviation 177.48	251.07 Scores on a scale*hours Standard Deviation 94.99	200.33 Scores on a scale*hours Standard Deviation 167.29	133.70 Scores on a scale*hours Standard Deviation 84.38	348.49 Scores on a scale*hours Standard Deviation 169.76
11-point (0-10) Numerical Pain Rating Scale (NPRS) AUC 24 hours - 1 week	294.12 Scores on a scale*hours Standard Deviation 258.23	534.62 Scores on a scale*hours Standard Deviation 423.60	512.52 Scores on a scale*hours Standard Deviation 269.58	317.30 Scores on a scale*hours Standard Deviation 264.28	212.07 Scores on a scale*hours Standard Deviation 144.15	718.80 Scores on a scale*hours Standard Deviation 422.15
11-point (0-10) Numerical Pain Rating Scale (NPRS) AUC 24 hours - 2 weeks	555.60 Scores on a scale*hours Standard Deviation 583.64	1150.53 Scores on a scale*hours Standard Deviation 1127.42	972.87 Scores on a scale*hours Standard Deviation 816.65	561.00 Scores on a scale*hours Standard Deviation 429.33	452.37 Scores on a scale*hours Standard Deviation 379.82	1588.12 Scores on a scale*hours Standard Deviation 1165.62

SECONDARY outcome

Timeframe: Daily up through Day 15

Use of postoperative analgesic therapy/treatments

Opioid consumption is recorded on the concomitant medication and/or the rescue medications pages and is calculated as the sum of the morphine milligram equivalents (MEQ) of all the medications recorded as taken during the period. For subjects who discontinued from the efficacy portion of the study, all medications are included regardless of whether they were taken before or after the discontinuation

Outcome measures

Measure	Cohort 1 n=6 Participants CA-008 in 0.5 mg dose	Cohort 2 n=6 Participants CA-008 in 1 mg dose	Cohort 3 n=6 Participants CA-008 in 2 mg dose	Cohort 4 n=6 Participants CA-008 in 3 mg dose	Cohort 5 n=6 Participants CA-008 in 4.2 mg dose	Placebo n=10 Participants Placebo administration
Postoperative Use of Analgesics	40.00 Morphine milligram equivalents (MEQ) Standard Deviation 39.02	38.17 Morphine milligram equivalents (MEQ) Standard Deviation 39.78	68.75 Morphine milligram equivalents (MEQ) Standard Deviation 79.86	42.50 Morphine milligram equivalents (MEQ) Standard Deviation 41.53	47.50 Morphine milligram equivalents (MEQ) Standard Deviation 47.59	94.60 Morphine milligram equivalents (MEQ) Standard Deviation 58.15

Adverse Events

CA-008 Cohort 1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

CA-008 Cohort 2

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

CA-008 Cohort 3

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

CA-008 Cohort 4

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

CA-008 Cohort 5

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CA-008 Cohort 1 n=6 participants at risk CA-008 in 0.5 mg	CA-008 Cohort 2 n=6 participants at risk CA-008 in 1 mg	CA-008 Cohort 3 n=6 participants at risk CA-008 in 2 mg	CA-008 Cohort 4 n=6 participants at risk CA-008 in 3 mg	CA-008 Cohort 5 n=6 participants at risk CA-008 in 4.2 mg	Placebo n=10 participants at risk Placebo administration
Eye disorders Blepharitis	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Constipation	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Nausea	33.3% 2/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Muscle Strain	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Skin abrasion	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Injury, poisoning and procedural complications Wound complication	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Musculoskeletal and connective tissue disorders Back Pain	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Nervous system disorders Dizziness	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Nervous system disorders Hyperaesthesia	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Nervous system disorders Syncope	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/10 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Nervous system disorders Headache	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	0.00% 0/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	16.7% 1/6 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.	10.0% 1/10 • Adverse event data were collected up to 64 days for participants in the study. This was comprised of a screening period that could be up to 28 days and subsequent clinic visits through Day 29. A Day 36 visit was required only if the wound was not considered healed by Day 29. The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.

Additional Information

Dr. John Donovan, President and Founder

Concentric Analgesics

Phone: 415-676-8940

Email: JOHN@CONCENTRICANALGESICS.COM

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60