Nitric Oxide Releasing Solution (NORS) Footbath to Treat Athlete's Foot

• Sponsor: Nitric Solutions Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02871011
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.3
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the fungicidal efficacy of nitric oxide releasing solution footbath and it's effect on the clinical signs and symptoms associated with Tinea Pedis

Condition or Disease	Intervention/Treatment	Phase
Tinea Pedis	Drug: Nitric Oxide; Drug: Water	Phase 2

Detailed Description

Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification:

Efficacy Study Intervention Model: Sequential Assignment Masking: Double Blind (Subject & Assessor) Primary Purpose: Treatment

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Blinded Placebo Controlled Clinical Trial To Evaluate Fungicidal Activity With The Topical Application Of Nitric Oxide Releasing Solution (Nors) In Subjects With Moderate To Severe Tinea Pedis (Athlete's Foot)
• Actual Study Start Date: Aug 13, 2016
• Actual Primary Completion Date: Nov 14, 2016
• Actual Study Completion Date: Feb 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days.	Drug: Water; Delivered as a footbath; Other Names: Placebo
Experimental: Nitric oxide Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days.	Drug: Nitric Oxide; Delivered as a footbath; Other Names: NORS

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Complete Cure: Post Treatment (Day 17) [Day 17]

   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.

2. Number of Participants With Complete Cure: Post Treatment (Day 31) [Day 31]

   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.

3. Number of Participants With Therapeutic Failure: Post Treatment (Day 17) [Day 17]

   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.

4. Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8. [Day 31]

   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.

5. Incidence of Adverse Events [Duration of the study, 31 days for each participant.]

   Number of moderate A/E possibly related to treatment

Secondary Outcome Measures

1. Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31 [Day 1 and 31]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Positive clinical findings for moccasin, interdigital or bullous tinea pedis as determined by direct clinical examination

• Must have a clinical symptom severity score of at least 20 on a possible 64 point scale

• Written informed consent must be obtained from the subject.

• Must ≥ 19 years of age, for study sites located in British Columbia. For other locations the subject must be ≥ 18 years of age, unless local laws dictate otherwise.

• Must agree to avoid professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit until the conclusion of the trial.

• Must agree to take measures to avoid pregnancy during the 31 day study period

Exclusion Criteria:

• Has a diagnosis of either psoriasis or eczema, in or immediately around the area under evaluation.

• Has a visual diagnosis, by the investigator, of onychomycosis at a level, which in the opinion of the investigator could compromise the integrity of the study.

• Use of topical antifungals e.g. (clotrimazole, ketoconazole,miconazole, oxiconazole- (Oxistat®, Glaxo Smith Kline), sulconazole, naftifine (Naftin®, Merz), terconazole, econazole nitrate (Spectazole®, Ortho-McNeil), butoconazole ,Fluconazole, ciclopirox olamine-(Loprox®), tolnaftate, haloprogin), Zeasorb, antibacterials and corticosteroids in the preceding 5 days of screening visit (Day 1) on or immediately around the area under evaluation.

• Use of systemic corticosteroids in the preceding 7 days respectively, of screening visit (Day 1)

• Use of systemic antifungals in the preceding 7 days of screening visit (Day1) including - (terbinafine - (Lamisil®, Novartis), Itraconazole - (Sporanox®, Janssen), fluconazole- (Diflucan®, Pfizer), ketoconazole, miconazole, griseofulvin (GrisPEG®), butoconazole, terconazole, Potassium iodide)

• Has used any investigational drug(s) within 30 days preceding screening visit (Day 1)

• Is pregnant or is a nursing mother

• Is a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)

• Is < 19 years of age, for study sites located in British Columbia. For other locations subject is < 18 years of age, unless local laws dictate otherwise.

• Suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety and / or the quality of the data. Such conditions may include collagen vascular disease, diabetes mellitus, Cushing's Disease, hematological malignancy, chronic mucocutaneous candidiasis or atopy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fairmont Medical Clinic	Vancouver	British Columbia	Canada	V5Z-16H

Sponsors and Collaborators

• Nitric Solutions Inc.

Investigators

• Principal Investigator: Lisa Miller, M.D., Nitric Solutions Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nitric Solutions Inc.
• ClinicalTrials.gov Identifier: NCT02871011
• Other Study ID Numbers: SAN-CPT-01
• First Posted: Aug 18, 2016
• Last Update Posted: Sep 20, 2019
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Nitric Solutions Inc.: Tinea Bronchodilator Agents; Tinea Pedis; Nitric Oxide; Dermatomycoses; Endothelium-Dependent Relaxing Factors; Infectious; Infection; Mycoses; Skin Diseases; Foot Dermatoses; Foot Diseases; Pruritus; Skin Manifestations Signs and Symptoms
• Additional relevant MeSH terms: Tinea; Tinea Pedis; Nitric Oxide

Study Results

Participant Flow

Arm/Group Title	Control	Nitric Oxide
Arm/Group Description	Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath
Period Title: Overall Study
STARTED	7	13
COMPLETED	7	13
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Control	Nitric Oxide	Total
Arm/Group Description	Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath	Total of all reporting groups
Overall Participants	7	13	20
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	53.1	53.2	53.2
Sex: Female, Male (Count of Participants)
Female	0 0%	3 23.1%	3 15%
Male	7 100%	10 76.9%	17 85%
Region of Enrollment (participants) [Number]
Canada	7 100%	13 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Complete Cure: Post Treatment (Day 17)
Description	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.
Time Frame	Day 17

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Control	Nitric Oxide
Arm/Group Description	Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath
Measure Participants	4	8
Count of Participants [Participants]	0 0%	4 30.8%

2. Primary Outcome

Title	Number of Participants With Complete Cure: Post Treatment (Day 31)
Description	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.
Time Frame	Day 31

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Control	Nitric Oxide
Arm/Group Description	Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath
Measure Participants	4	8
Count of Participants [Participants]	0 0%	5 38.5%

3. Primary Outcome

Title	Number of Participants With Therapeutic Failure: Post Treatment (Day 17)
Description	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.
Time Frame	Day 17

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Control	Nitric Oxide
Arm/Group Description	Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath
Measure Participants	4	8
Count of Participants [Participants]	2 28.6%	0 0%

4. Primary Outcome

Title	Number of Participants withTherapeutic Failure: Post Treatment Day 31 AND a Post Treatment Clinical Symptom Severity Score (Day 31) of < 8.
Description	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.
Time Frame	Day 31

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Control	Nitric Oxide
Arm/Group Description	Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath
Measure Participants	4	8
Count of Participants [Participants]	1 14.3%	0 0%

5. Primary Outcome

Title	Incidence of Adverse Events
Description	Number of moderate A/E possibly related to treatment
Time Frame	Duration of the study, 31 days for each participant.

Outcome Measure Data

Analysis Population Description

Intent to treat enrollment was 20 individuals.

Arm/Group Title	Control	Nitric Oxide
Arm/Group Description	Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath
Measure Participants	7	13
Number [Events]	0	3

6. Secondary Outcome

Title	Change in Participants Clinical Symptom Severity Score Between Day 1 and Day 31
Description	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.
Time Frame	Day 1 and 31

Outcome Measure Data

Analysis Population Description

Intent to treat enrollment was 20 individuals.

Arm/Group Title	Control	Nitric Oxide
Arm/Group Description	Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath	Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath
Measure Participants	7	13
Mean (Standard Deviation) [Clinial symptom Severity Score]	-3.4 (8.6)	-18.8 (7.1)

Adverse Events

Time Frame	Thirty-one Days
Arm/Group Title	Control		Nitric Oxide
Arm/Group Description	Water, delivered as a footbath for 30 minutes, daily for 3 consecutive days. Water: Delivered as a footbath		Nitric oxide delivered as a footbath for 30 minutes, daily for 3 consecutive days. Nitric Oxide: Delivered as a footbath
All Cause Mortality
	Control		Nitric Oxide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/13 (0%)
Serious Adverse Events
	Control		Nitric Oxide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Control		Nitric Oxide
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		3/13 (23.1%)
Skin and subcutaneous tissue disorders
Discomfort -warm/sting	0/7 (0%)	0	3/13 (23.1%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.