Irritation/IrritantPhase 1NCT02198963

21 Day Cumulative Skin Irritation of RUT058-60

A Phase 1 study testing Hypochlorous acid solution 106 mg/L, 0.1% (w/v) Sodium Lauryl Sulfate and 0.9% Physiological Saline, USP in people with Irritation/Irritant, run by Pulmatrix Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine the skin irritation potential of RUT058-60 after repetitive patch application to abraded and non-abraded skin of human subjects. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Irritation/Irritant
What is being tested?: Hypochlorous acid solution 106 mg/L, 0.1% (w/v) Sodium Lauryl Sulfate and 0.9% Physiological Saline, USP
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 43 participants
Where: 1 siteUnited States
Study dates: Jul 2014to Sep 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects may be of either sex, at least 18 years of age and of any race
Subjects must be free of tattoos, sunburn, dermatoses, cuts, lesions, or other disorders on the parascapular skin of the back
Subjects must be in good general health, as evidenced by the Subject Confidential Information and Acceptance Criteria and confirmed by screening laboratory evaluations
Subjects must read and sign an Informed Consent Form, Subject Confidential Information and Acceptance Criteria, Authorization to Use and Disclose Protected Health Information Form

Who cannot join

Known allergies to latex (rubber), metals, ink, tape and/or adhesives, soap, hypochlorous acid, sodium lauryl sulfate, physiological Saline
Exposure of the upper back region to antimicrobial agents, medicated soaps, medicated shampoos, medicated lotions, or strong detergents in the 7 days prior to, or during the 3-week test period; or sun-tanning, use of tanning beds, or swimming or soaking in pools or hot tubs
Use of topical or systemic corticosteroid, antihistamine, or anti-inflammatory medications in the 7 days prior to, or during the 3-week test period
A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised condition, such as AIDS (or HIV positive)
Pregnancy, plans to become pregnant within the pre-test period or test days of the study, or nursing a child. Women cannot be pregnant, as evidenced by a negative urine pregnancy test, or should be of non-childbearing potential; that is, surgically sterile or postmenopausal (amenorrhea for at least 12 months)
Any active skin rashes or breaks in the skin of the parascapular region of the back

Show all 12Show fewer

Any sunburn or tattoos on the skin of the parascapular region of the back
A currently active skin disease or inflammatory skin condition, including contact dermatitis
Participation in a clinical study in the past 7 days or current participation in another clinical study
Any medical condition or use of any medications that, in the opinion of the Principal Investigator, should preclude participation
Clinical laboratory assessments that are determined by the Principal Investigator to indicate a clinically relevant abnormality and/or an exclusionary medical condition
Unwillingness to fulfill the performance requirements of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

BioScience Laboratories, Inc.
Butte, Montana, 59701

Other trials in United States

About this study

Official title: Phase 1 21-Day Evaluation of the Cumulative Irritation Potential of RUT058-60 on Abraded and Non-Abraded Skin Sites

The purpose of this study is to determine the skin irritation potential of RUT058-60 after repetitive patch application to abraded and non-abraded skin of human subjects.

Read the detailed description

This Cumulative Irritation Evaluation is designed to determine the skin irritation potential of RUT058-60, after repetitive patch application to abraded and non-abraded skin of healthy human subjects. Abraded skin will be challenged because the Test Product may be used, in practice, on non-intact skin. The primary research objective in this study is determine the skin irritation potential of RUT058-60. This question will be answered based on the observed results acquired evaluating its application to the abraded and non-abraded skin of at least 30 volunteer subjects, on the test product relative to the control readings.

A sufficient number of subjects will be recruited into the study to ensure 30 subjects, including both males and females, complete the study. Prior to the first application of test materials, designated skin sites will be abraded using the Tape Stripping Procedure. Occlusive patches will be used to apply approximately 0.02 mL of Test Product, Positive Control and Negative Control to abraded and non-abraded sites on the skin in the scapular region of each subject's back. The irritation potential of the test materials will be determined over the course of a 21-day challenge period on at least 30 subjects. A test material will be applied to the same site, abraded and non-abraded, on each day for 21 days. The six skin sites will be evaluated visually prior to each patch application and following the final patch removal.

Conditions: Irritation/Irritant
Being tested: Hypochlorous acid solution 106 mg/L, 0.1% (w/v) Sodium Lauryl Sulfate, 0.9% Physiological Saline, USP
Keywords: Skin irritation potential of RUT058-60.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hypochlorous acid solution 106 mg/LDrug
Also called RUT058-60
test product
0.1% (w/v) Sodium Lauryl SulfateDrug
Also called SLS
positive control
0.9% Physiological Saline, USPDrug
Also called sterile saline
negative control

Study groups in NCT02198963
Study group	Role	What they receive
Hypochlorous acid Solution 106 mg/L	Experimental	Occlusive patches will be used to apply approximately 0.02 mL of the Test Product RUT058-60 to abraded and non-abraded sites on the skin in the scapular region of each subject's back. Receives: Drug: Hypochlorous acid solution 106 mg/L
0.1% (w/v) Sodium Lauryl Sulfate	Active comparator	Occlusive patches will be used to apply approximately 0.02 mL of the Positive Control (0.1% Sodium Lauryl Sulfate) to abraded and non-abraded sites on the skin in the scapular region of each subject's back, once daily for 21 days. Receives: Drug: 0.1% (w/v) Sodium Lauryl Sulfate
0.9% Physiological Saline, USP	Placebo comparator	Occlusive patches will be used to apply approximately 0.02 mL of the Negative Control (0.9% Physiological Saline, USP) to abraded and non-abraded sites on the skin in the scapular region of each subject's back, once daily for 21 days. Receives: Drug: 0.9% Physiological Saline, USP

What is being measured

The primary outcome is the main question the study is designed to answer.

Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin
Primary Analysis After a 23-hour ± 1-hour period of exposure, patches were removed, and the sites evaluated and visually scored for irritancy. The procedures will be repeated on the same test sites an additional twenty times. On each day,mean values, sample sizes, ranges, etc., of the irritation scores, for a total of six configurations, were recorded.
Grading Scale for Visual Evaluation of Skin Condition: 0= no evidence of irritation, 1= minimal erythema, barely perceptible, 2= definite erythema, readily visible; minimal edema or minimal papular response, 3= erythema and papules, 4= definite edema, 5= erythema, edema, and papules, 6=' vesicular eruption, 7= strong reaction spreading beyond test site Visual observations of 3, 4, or 5 resulted in discontinuance of product application to that site. Observations of 6 or 7 were considered an adverse event and subject discontinued from the study.
Measured: 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Sep 2014

First posted24 Jul 2014 (estimated)
Study startJul 2014
Primary completionAug 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Irritation/IrritantStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02198963
Sponsor's protocol ID: CP01-117838
Other IDs: 130932-304.01
Status last verified: Feb 2016
First submitted: 18 Jul 2014
Last updated: 4 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1 21-Day Evaluation of the Cumulative Irritation Potential of RUT058-60 on Abraded and Non-Abraded Skin Sites
ClinicalTrials.gov ID: NCT02198963
Acronym / sponsor ID: CP01-117838
Conditions: Irritation/Irritant
Keywords: Skin irritation potential of RUT058-60.
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Pulmatrix Inc.Industry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Aug 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 24 Jul 2014 (estimated)
Results: Posted 4 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to determine the skin irritation potential of RUT058-60 after repetitive patch application to abraded and non-abraded skin of human subjects.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Hypochlorous acid Solution 106 mg/L	Experimental	Drug: Hypochlorous acid solution 106 mg/LOcclusive patches will be used to apply approximately 0.02 mL of the Test Product RUT058-60 to abraded and non-abraded sites on the skin in the scapular region of each subject's back.
0.1% (w/v) Sodium Lauryl Sulfate	Active comparator	Drug: 0.1% (w/v) Sodium Lauryl SulfateOcclusive patches will be used to apply approximately 0.02 mL of the Positive Control (0.1% Sodium Lauryl Sulfate) to abraded and non-abraded sites on the skin in the scapular region of each subject's back, once daily for 21 days.
0.9% Physiological Saline, USP	Placebo comparator	Drug: 0.9% Physiological Saline, USPOcclusive patches will be used to apply approximately 0.02 mL of the Negative Control (0.9% Physiological Saline, USP) to abraded and non-abraded sites on the skin in the scapular region of each subject's back, once daily for 21 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subjects may be of either sex, at least 18 years of age and of any race
Subjects must be free of tattoos, sunburn, dermatoses, cuts, lesions, or other disorders on the parascapular skin of the back
Subjects must be in good general health, as evidenced by the Subject Confidential Information and Acceptance Criteria and confirmed by screening laboratory evaluations
Subjects must read and sign an Informed Consent Form, Subject Confidential Information and Acceptance Criteria, Authorization to Use and Disclose Protected Health Information Form

Key exclusion criteria (12 listed)

Known allergies to latex (rubber), metals, ink, tape and/or adhesives, soap, hypochlorous acid, sodium lauryl sulfate, physiological Saline
Exposure of the upper back region to antimicrobial agents, medicated soaps, medicated shampoos, medicated lotions, or strong detergents in the 7 days prior to, or during the 3-week test period; or sun-tanning, use of tanning beds, or swimming or soaking in pools or hot tubs
Use of topical or systemic corticosteroid, antihistamine, or anti-inflammatory medications in the 7 days prior to, or during the 3-week test period
A medical diagnosis of a physical condition, such as a current or recent severe illness, asthma, diabetes, hepatitis, an organ transplant, mitral valve prolapse, congenital heart disease, internal prostheses, or any immunocompromised condition, such as AIDS (or HIV positive)
Pregnancy, plans to become pregnant within the pre-test period or test days of the study, or nursing a child. Women cannot be pregnant, as evidenced by a negative urine pregnancy test, or should be of non-childbearing potential; that is, surgically sterile or postmenopausal (amenorrhea for at least 12 months)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hypochlorous acid solution 106 mg/LAlso: RUT058-60test product	Drug	Hypochlorous acid Solution 106 mg/L
0.1% (w/v) Sodium Lauryl SulfateAlso: SLSpositive control	Drug	0.1% (w/v) Sodium Lauryl Sulfate
0.9% Physiological Saline, USPAlso: sterile salinenegative control	Drug	0.9% Physiological Saline, USP

Primary outcome

Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin
Time frame: 21 days
Primary Analysis After a 23-hour ± 1-hour period of exposure, patches were removed, and the sites evaluated and visually scored for irritancy. The procedures will be repeated on the same test sites an additional twenty times. On each day,mean values, sample sizes, ranges, etc., of the irritation scores, for a total of six configurations, were recorded. Grading Scale for Visual Evaluation of Skin Condition: 0= no evidence of irritation, 1= minimal erythema, barely perceptible, 2= definite erythema, readily visible; minimal edema or minimal papular response, 3= erythema and papules, 4= definite edema, 5= erythema, edema, and papules, 6=' vesicular eruption, 7= strong reaction spreading beyond test site Visual observations of 3, 4, or 5 resulted in discontinuance of product application to that site. Observations of 6 or 7 were considered an adverse event and subject discontinued from the study.

Results and safety

Results posted to the registry on 4 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RUT058-60 vs Negative Control vs Positive Control	43	36

Primary outcome: Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin

Time frame: 21 days. Mean (Standard Deviation). Unit: units on a scale

Measure	Hypochlorous Acid Solution 106 mg/L-Abraded n = 36	Sodium Lauryl Sulfate (0.1%) -Abraded n = 36	Physiological Saline (0.9%), USP-Abraded n = 36	Hypochlorous Acid Solution 106 mg/L- Non-Abraded n = 36	Sodium Lauryl Sulfate (0.1%)- Non-Abraded n = 36	Physiological Saline (0.9%), USP- Non-Abraded n = 36
Value	1.00 (0.68)	2.46 (0.55)	1.34 (0.44)	0.58 (0.33)	1.84 (0.58)	0.82 (0.51)

Population analysed: Each subject had each study material (test, positive and negative controls) applied to separate abraded and non-abraded skin sites

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RUT058-60 vs Negative and Positve Controls	0 of 43 (0%)	5 of 43 (11.6%)	Not reported

Limitations and caveats (from the sponsor): Results from 36 subjects receiving all applications and completing all visits

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John Pullman, M.D. principal investigator

BioScience Laboratories, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Irritation Score of RUT058-60 Hypochlorous Acid Solution (106 mg/L) on Healthy Human Skin (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02198963.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.