Trial Outcomes & Findings for Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot (NCT NCT02871011)

Results Overview

Complete cure will be determined by negative fungal culture or negative microscopic evaluation via KOH preparation and a Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Day 17

Results posted on

2019-09-20

Participant Flow

Participant milestones

Participant milestones
Measure	Control Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric Oxide Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath
Overall Study STARTED	7	13
Overall Study COMPLETED	7	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Treatment to Control of 2:1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=7 Participants Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric Oxide n=13 Participants Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath	Total n=20 Participants Total of all reporting groups
Age, Continuous	53.1 years n=5 Participants • Randomized Treatment to Control of 2:1	53.2 years n=7 Participants • Randomized Treatment to Control of 2:1	53.2 years n=5 Participants • Randomized Treatment to Control of 2:1
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment Canada	7 participants n=5 Participants	13 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 17

Population: Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline.

Complete cure will be determined by negative fungal culture or negative microscopic evaluation via KOH preparation and a Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score.

Outcome measures

Outcome measures
Measure	Control n=4 Participants Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric Oxide n=8 Participants Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath
Number of Participants With Complete Cure: Post Treatment (Day 17)	0 Participants	4 Participants

PRIMARY outcome

Timeframe: Day 31

Population: Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline.

Complete cure will be determined by a minimum of a 12- point reduction on day 17 in the Clinical Symptom Severity Score (from \>20 to \<8) on a scale of 0-64. Improvement is expressed as a lower score.

Outcome measures

Outcome measures
Measure	Control n=4 Participants Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric Oxide n=8 Participants Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath
Number of Participants With Complete Cure: Post Treatment (Day 31)	0 Participants	5 Participants

PRIMARY outcome

Timeframe: Day 17

Population: Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline.

Positive fungi colonization via mycological culture OR microscopic evaluation (KOH) AND a post treatment Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 17. Improvement is expressed as a lower score.

Outcome measures

Outcome measures
Measure	Control n=4 Participants Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric Oxide n=8 Participants Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath
Number of Participants With Therapeutic Failure: Post Treatment (Day 17)	2 Participants	0 Participants

PRIMARY outcome

Timeframe: Day 31

Population: Intent to treat enrollment was 20 individuals but per protocol only a total of 12 participants met the criteria for both a positive fungal culture and microscopic evaluation at baseline.

Positive fungi colonization via mycological culture OR microscopic evaluation (KOH) AND a post treatment Clinical Symptom Severity Score of ≤ 8 (0-64) on Day 31. Improvement is expressed as a lower score.

Outcome measures

Outcome measures
Measure	Control n=4 Participants Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric Oxide n=8 Participants Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath
Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8.	1 Participants	0 Participants

PRIMARY outcome

Timeframe: Duration of the study, 31 days for each participant.

Population: Intent to treat enrollment was 20 individuals.

Number of moderate A/E possibly related to treatment

Outcome measures

Outcome measures
Measure	Control n=7 Participants Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric Oxide n=13 Participants Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath
Incidence of Adverse Events	0 Events	3 Events

SECONDARY outcome

Timeframe: Day 1 and 31

Population: Intent to treat enrollment was 20 individuals.

Clinical Symptom Severity Score change in score on Day and Day 31 between all participants with an initial Clinical Symptom severity Score of \>20 (0-64 scale) in the two study groups. Increased improvement is expressed as largest negative change and a lower score.

Outcome measures

Outcome measures
Measure	Control n=7 Participants Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric Oxide n=13 Participants Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath
Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31	-3.4 Clinial symptom Severity Score Standard Deviation 8.6	-18.8 Clinial symptom Severity Score Standard Deviation 7.1

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nitric Oxide

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control n=7 participants at risk Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric Oxide n=13 participants at risk Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath
Skin and subcutaneous tissue disorders Discomfort -warm/sting	0.00% 0/7 • Thirty-one Days	23.1% 3/13 • Number of events 3 • Thirty-one Days

Additional Information

Dr Chris Miller

SaNOtize Research & Development Corp.

Phone: 778-899-0607

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place