Trial Outcomes & Findings for Study of Cingal™ for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide (NCT NCT03191903)

NCT ID: NCT03191903

Last Updated: 2022-02-24

Results Overview

The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal group to the TH group. The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the change from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

576 participants

Primary outcome timeframe

26 weeks

Results posted on

2022-02-24

Participant Flow

Subjects were recruited at trial sites into the Cingal 16-02 study in May 2017 through September 2017.

One participant met the screening eligibility criteria but failed the baseline screening criteria due to aspirate criteria. This subject was not treated.

Participant milestones

Participant milestones
Measure	Cingal Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.	Monovisc Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.	Triamcinolone Hexacetonide (TH) Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Overall Study STARTED	251	251	74
Overall Study Intent to Treat Population	251	251	74
Overall Study COMPLETED	244	246	70
Overall Study NOT COMPLETED	7	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Cingal Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.	Monovisc Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.	Triamcinolone Hexacetonide (TH) Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Overall Study Withdrawal by Subject	6	5	4
Overall Study Adverse Event	1	0	0

Baseline Characteristics

Study of Cingal™ for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cingal n=251 Participants Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.	Monovisc n=251 Participants Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.	Triamcinolone Hexacetonide (TH) n=74 Participants Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.	Total n=576 Participants Total of all reporting groups
Age, Continuous	58.0 years STANDARD_DEVIATION 8.7 • n=5 Participants	57.7 years STANDARD_DEVIATION 8.9 • n=7 Participants	59.0 years STANDARD_DEVIATION 8.5 • n=5 Participants	58.0 years STANDARD_DEVIATION 8.7 • n=4 Participants
Sex: Female, Male Female	179 Participants n=5 Participants	163 Participants n=7 Participants	52 Participants n=5 Participants	394 Participants n=4 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	88 Participants n=7 Participants	22 Participants n=5 Participants	182 Participants n=4 Participants
Race/Ethnicity, Customized Caucasian	251 Participants n=5 Participants	251 Participants n=7 Participants	74 Participants n=5 Participants	576 Participants n=4 Participants
Baseline WOMAC Pain in Index Knee	63.3 units on a scale STANDARD_DEVIATION 11.0 • n=5 Participants	63.3 units on a scale STANDARD_DEVIATION 11.3 • n=7 Participants	63.8 units on a scale STANDARD_DEVIATION 11.3 • n=5 Participants	63.4 units on a scale STANDARD_DEVIATION 11.2 • n=4 Participants

PRIMARY outcome

Timeframe: 26 weeks

Population: Intent to Treat Population - all enrolled subjects

Outcome measures

Outcome measures
Measure	Cingal n=251 Participants Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.	Monovisc n=251 Participants Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.	Triamcinolone Hexacetonide (TH) n=74 Participants Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Change From Baseline in WOMAC Pain Score at 26 Weeks (ITT Population)	-46.4 units on a scale Standard Deviation 19.9	-46.6 units on a scale Standard Deviation 19.1	-45.0 units on a scale Standard Deviation 21.1

SECONDARY outcome

Timeframe: 3 weeks

Population: Intent to Treat Population (ITT): all enrolled subjects

The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal group to the Monovisc group. The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the change from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.

Outcome measures

Outcome measures
Measure	Cingal n=251 Participants Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.	Monovisc n=251 Participants Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.	Triamcinolone Hexacetonide (TH) n=74 Participants Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Change From Baseline in WOMAC Pain Score at 3 Weeks (ITT Population)	-42.6 score on a scale Standard Deviation 20.0	-39.5 score on a scale Standard Deviation 20.4	-41.3 score on a scale Standard Deviation 19.7

SECONDARY outcome

Timeframe: 26 weeks

Population: Intent to Treat Population (ITT) - all enrolled subjects

The responder rate as identified by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) responder index at 26 weeks post treatment comparing the Cingal® group to the TH group. The OMERACT-OARSI responder index is a proportion of subjects that met the criteria to be a responder.

Outcome measures

Outcome measures
Measure	Cingal n=251 Participants Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.	Monovisc n=251 Participants Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.	Triamcinolone Hexacetonide (TH) n=74 Participants Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
OMERACT-OARSI Responder Index at 26 Weeks Post Treatment Comparing the Cingal Group to the TH Group (ITT Population)	91.24 percentage of subjects	93.63 percentage of subjects	94.59 percentage of subjects

SECONDARY outcome

Timeframe: 26 weeks

Population: Intent to Treat Population (ITT) - all enrolled subjects

The change from baseline of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Score comparing the Cingal and TH arms (ITT Population). The WOMAC Physical Function Score is a validated visual analog scale from 0 = no limitations in function to 100 mm = highest limitations in function. A negative number for the change from baseline indicates improvement in physical function. A greater negative difference from baseline means a better outcome.

Outcome measures

Outcome measures
Measure	Cingal n=251 Participants Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.	Monovisc n=251 Participants Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.	Triamcinolone Hexacetonide (TH) n=74 Participants Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Change From Baseline in WOMAC Physical Function Score at 26 Weeks (ITT Population)	-42.6 units on a scale Standard Error 2.85	-42.4 units on a scale Standard Error 2.85	-42.4 units on a scale Standard Error 2.85

SECONDARY outcome

Timeframe: 26 weeks

Population: Intent to Treat Population (ITT) - all enrolled subjects

The change from baseline in knee stiffness as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Score comparing the Cingal group to the TH group. The WOMAC Stiffness Score is a validated visual analog scale from 0 = no stiffness to 100 = highest stiffness level. A negative number for the change from baseline indicates reduction in knee stiffness. A greater negative difference from baseline means a better outcome.

Outcome measures

Outcome measures
Measure	Cingal n=251 Participants Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.	Monovisc n=251 Participants Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.	Triamcinolone Hexacetonide (TH) n=74 Participants Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Change From Baseline in WOMAC Stiffness Score at 26 Weeks (ITT Population)	-39.4 units on a scale Standard Error 3.17	-41.1 units on a scale Standard Error 3.17	-38.5 units on a scale Standard Error 3.17

SECONDARY outcome

Timeframe: 26 weeks

Population: Intent to Treat Population (ITT) - all enrolled subjects

The change from baseline in Total Score as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) comparing the Cingal group to the TH group. The Total WOMAC Score combines the three 0-to-100 point scores from the WOMAC Pain Score, the WOMAC Stiffness Score, and the WOMAC Physical Function Score for a Total Score from 0 = no symptoms to 300 = highest degrees of pain, stiffness, and functional limitation symptoms. A negative number for the change from baseline indicates reduction in pain, stiffness and function limitations. A greater negative difference from baseline means a better outcome.

Outcome measures

Outcome measures
Measure	Cingal n=251 Participants Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.	Monovisc n=251 Participants Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.	Triamcinolone Hexacetonide (TH) n=74 Participants Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Change From Baseline in Total WOMAC Score at 26 Weeks (ITT Population)	-128.3 score on a scale Standard Error 8.03	-130.1 score on a scale Standard Error 8.03	-125.9 score on a scale Standard Error 8.03

SECONDARY outcome

Timeframe: 26 weeks

Population: Intent to Treat (all enrolled subjects)

The change from baseline in the Patient Global Assessment (PGA) between the Cingal and TH arms (ITT population). The PGA is completed by the subject answering the question "Considering all the ways the osteoarthritis in your index knee bothers you, what is your assessment of how much your knee is bothering you today?" The PGA is scored on a visual analog scale, where 0 = the patient is not bothered to 100 mm = the patient is bothered to the highest degree. A negative number for the change from baseline indicates an improvement in the patient assessment. A greater negative difference means a better outcome.

Outcome measures

Outcome measures
Measure	Cingal n=251 Participants Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.	Monovisc n=251 Participants Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.	Triamcinolone Hexacetonide (TH) n=74 Participants Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Change From Baseline in Patient Global Assessment at 26 Weeks (ITT Population)	-37.2 score on a scale Standard Error 3.37	-37.3 score on a scale Standard Error 3.37	-37.9 score on a scale Standard Error 3.37

SECONDARY outcome

Timeframe: 26 weeks

Population: Intent to Treat (all enrolled subjects)

The change from baseline in the Evaluator Global Assessment between the Cingal and TH arms (ITT population). The Evaluator Global Assessment is completed by the Blinded Outcomes Assessor, and answers the question "Considering all the ways the osteoarthritis in the patient's index knee bothers him/her, what is your assessment of how much the patient's knee is bothering him/her today?" The Evaluator Global Assessment is scored on a visual analog scale where 0 = the patient is not bothered, to 100 mm = the patient is bothered to the highest degree. A negative number for the change from baseline indicates improvement in the assessment. A greater negative difference means a better outcome.

Outcome measures

Outcome measures
Measure	Cingal n=251 Participants Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.	Monovisc n=251 Participants Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.	Triamcinolone Hexacetonide (TH) n=74 Participants Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Change From Baseline in the Evaluator Global Assessment at 26 Weeks (ITT Population)	-37.4 score on a scale Standard Error 2.73	-36.4 score on a scale Standard Error 2.73	-38.8 score on a scale Standard Error 2.73

SECONDARY outcome

Timeframe: 1 week

Population: Intent to Treat Population (ITT) - all enrolled subjects

Outcome measures

Outcome measures
Measure	Cingal n=251 Participants Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.	Monovisc n=251 Participants Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.	Triamcinolone Hexacetonide (TH) n=74 Participants Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Change From Baseline in WOMAC Pain Score at 1 Week (ITT Population)	-35.3 score on a scale Standard Deviation 20.7	-33.0 score on a scale Standard Deviation 21	-34.5 score on a scale Standard Deviation 20.7

SECONDARY outcome

Timeframe: 26 weeks

Population: Intent to Treat Population (ITT) - all enrolled subjects

The usage of rescue medication (acetominophen) through 26 weeks post treatment in the Cingal group compared to the TH group using the ITT population.

Outcome measures

Outcome measures
Measure	Cingal n=251 Participants Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.	Monovisc n=251 Participants Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.	Triamcinolone Hexacetonide (TH) n=74 Participants Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
The Usage of Rescue Medication (Acetaminophen) Through 26 Weeks (ITT Population)	5.4 pills Standard Deviation 19.3	5.9 pills Standard Deviation 16.0	6.3 pills Standard Deviation 17.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Weeks

Population: Per-Protocol Population (PP): The PP Population was defined as all subjects who completed the 26 Week Visit (since the primary end point was at 26 Weeks) and have no major protocol violations.

Outcome measures

Outcome measures
Measure	Cingal n=238 Participants Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.	Monovisc n=244 Participants Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.	Triamcinolone Hexacetonide (TH) n=69 Participants Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Change From Baseline in WOMAC Pain Score at 3 Weeks in the Per-Protocol Population	-43.4 score on a scale Standard Deviation 19.6	-39.8 score on a scale Standard Deviation 20.4	-42.5 score on a scale Standard Deviation 18.1

Adverse Events

Cingal

Serious events: 7 serious events

Other events: 101 other events

Deaths: 0 deaths

Monovisc

Serious events: 0 serious events

Other events: 101 other events

Deaths: 0 deaths

Triamcinolone Hexacetonide (TH)

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cingal n=251 participants at risk Cingal is a combination product consisting of 88 milligrams of cross-linked HA (hyaluronic acid) with 18 milligrams of TH (triamcinolone hexacetonide) in a 4 milliliter (mL) intra-articular injection.	Monovisc n=251 participants at risk Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection.	Triamcinolone Hexacetonide (TH) n=74 participants at risk Triamcinolone hexacetonide (TH) is a corticosteroid supplied in a 20 milligram per 1 milliliter (20 mg/mL) intra-articular injection.
Nervous system disorders Sciatica	0.40% 1/251 • Number of events 1 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.	0.00% 0/251 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.	0.00% 0/74 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Fracture of lateral malleolus, closed	0.40% 1/251 • Number of events 1 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.	0.00% 0/251 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.	0.00% 0/74 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.
General disorders Delirium tremens	0.40% 1/251 • Number of events 1 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.	0.00% 0/251 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.	0.00% 0/74 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.
Surgical and medical procedures Foot operation	0.40% 1/251 • Number of events 1 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.	0.00% 0/251 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.	0.00% 0/74 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.
Ear and labyrinth disorders Inner ear inflammation	0.40% 1/251 • Number of events 1 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.	0.00% 0/251 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.	0.00% 0/74 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.
Injury, poisoning and procedural complications Head Injury	0.40% 1/251 • Number of events 1 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.	0.00% 0/251 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.	0.00% 0/74 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.
Skin and subcutaneous tissue disorders Dermatitis contact	0.40% 1/251 • Number of events 1 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.	0.00% 0/251 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.	0.00% 0/74 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.
Blood and lymphatic system disorders Varicose Vein	0.40% 1/251 • Number of events 1 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.	0.00% 0/251 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.	0.00% 0/74 • All Adverse Events that occurred after signing the Informed Consent Form to 26 weeks post treatment were recorded for all enrolled subjects (Safety Population). The definitions used for an adverse event and/or serious adverse event are consistent with the definitions used in clinicaltrials.gov.

Other adverse events

Additional Information

Carol Pekar, VP Clinical Affairs

Anika

Phone: 781-457-9218

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place