Surgical Site InfectionPhase 1NCT02160587
Safety Study to Evaluate the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA
A Phase 1 study testing Chloraprep, 0.9% Physiological Saline and ZuraPrep without IPA in people with Surgical Site Infection, run by Zurex Pharma, Inc. at 1 site in United States.
Trial summary
This is a safety study to determine the skin sensitization potential of ZuraPrep™ and ZuraPrep™ without isopropyl alcohol (IPA) after repetitive patch applications to skin of human subjects. Indications of both sensitization and skin irritation will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Chloraprep, 0.9% Physiological Saline and ZuraPrep without IPA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 of the skin of the back.
- Subjects must be in good general health
Who cannot join
- Known allergies to latex, metals, tape and/or adhesives, soap, citric acid, methylene blue, methylparaben, propylparaben, chlorhexidine gluconate, isopropyl alcohol, and sodium lauryl sulfate.
- Exposure of the back region to antimicrobial agents, medicated soaps, medicated shampoos, medicated lotions, strong detergents, sun-tanning, use of tanning beds, or swimming or soaking in pools or hot tubs, in the 7 days prior to, or during the 3-week test period.
- Use of topical or systemic corticosteroid, antihistamine, or anti-inflammatory medications in the 7 days prior to, or during the 3-week test period.
- Current or recent severe illness such as asthma, diabetes, hepatitis, 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, breast-feeding
- Any active skin rash or breaks in the skin of the back
Show all 11Show fewer
- Any sunburn or tattoos on the skin of the back
- Current 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, would preclude participation
- Unwillingness to fulfill the performance requirements of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
BioScience Laboratories, Inc.
Bozeman, Montana, 59718
About this study
Official title: A Clinical Evaluation of the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers
This is a safety study to determine the skin sensitization potential of ZuraPrep™ and ZuraPrep™ without isopropyl alcohol (IPA) after repetitive patch applications to skin of human subjects. Indications of both sensitization and skin irritation will be evaluated.
Read the detailed description
This study is designed to determine if the test product, ZuraPrep™ is a skin sensitizing agent when applied to human skin. The study, a modified Draize skin sensitization evaluation, will be conducted in three discrete phases: 1) induction, 2) rest, and 3) challenge. During the Induction Phase, skin sites are exposed to the test product repeatedly for 21 consecutive days. The Rest Phase, a 14-day period when no treatment is performed, serves to provide adequate time for the immune system to react to ZuraPrep™, given any of its components serve as antigens. During the Challenge Phase, the subjects' skin is re-exposed to the test product (ZuraPrep™) to determine if it is likely to be immunosensitizing.
- Conditions
- Surgical Site Infection
- Being tested
- Chloraprep, 0.9% Physiological Saline, ZuraPrep without IPA
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloraprepDrug
Also called Reference Product, 2% Chlorhexidine Gluconate and 70% IPA
ChloraPrep will be compared to ZuraPrep with regard to skin sensitization and irritation.
0.9% Physiological SalineDrug
Also called Negative Control
0.9% Physiological Saline will be compared to ZuraPrep with regard to skin sensitization and irritation.
ZuraPrep without IPAOther
Also called ZuraPrep without Isopropyl Alcohol (IPA)
ZuraPrep without IPA will be compared to ZuraPrep with regard to skin sensitization and irritation
| Study group | Role | What they receive |
|---|---|---|
| ZuraPrep | Active comparator | Irritation scores of the following applied to test sites will be compared: ZuraPrep, ZuraPrep without IPA, ChloraPrep, and 0.9% Physiological Saline. Receives: Drug: Chloraprep; Drug: 0.9% Physiological Saline; Other: ZuraPrep without IPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin sites evaluated and graded for irritancy or sensitization
Only frank sensitization will be categorized, as a positive control (known sensitizing agent) is prohibitive due to ethical considerations/risk of life-time sensitization. Reactions observed will be assessed as to whether indicative of sensitization or of irritation.
Measured: 0-40 days post dose
Secondary outcomes (1)
Statistics of irritation scores
Irritation scores, relative to the Test Products, Reference Product, and the Negative Control applied to skin on each test day will be compared as well as the total cumulative irritation scores across all test days.
Measured: 0-40 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurex Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maggie Butler, PhD, Principal investigator, BioScience Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160587
- Sponsor's protocol ID
- 130821-303 (ZX-ZP-0018)
- Status last verified
- Mar 2015
- First submitted
- 5 Jun 2014
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the Contact Sensitizing Potential of Topically Applied ZuraPrep™ and ZuraPrep™ Without IPA in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02160587
- Acronym / sponsor ID
- 130821-303 (ZX-ZP-0018)
- Conditions
- Surgical Site Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Zurex Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a safety study to determine the skin sensitization potential of ZuraPrep™ and ZuraPrep™ without isopropyl alcohol (IPA) after repetitive patch applications to skin of human subjects. Indications of both sensitization and skin irritation will be evaluated.
Detailed description
This study is designed to determine if the test product, ZuraPrep™ is a skin sensitizing agent when applied to human skin. The study, a modified Draize skin sensitization evaluation, will be conducted in three discrete phases: 1) induction, 2) rest, and 3) challenge. During the Induction Phase, skin sites are exposed to the test product repeatedly for 21 consecutive days. The Rest Phase, a 14-day period when no treatment is performed, serves to provide adequate time for the immune system to react to ZuraPrep™, given any of its components serve as antigens. During the Challenge Phase, the subjects' skin is re-exposed to the test product (ZuraPrep™) to determine if it is likely to be immunosensitizing.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ZuraPrep | Active comparator | Drug: Chloraprep, Drug: 0.9% Physiological Saline, Other: ZuraPrep without IPAIrritation scores of the following applied to test sites will be compared: ZuraPrep, ZuraPrep without IPA, ChloraPrep, and 0.9% Physiological Saline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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 of the skin of the back.
- Subjects must be in good general health
Key exclusion criteria (11 listed)
- Known allergies to latex, metals, tape and/or adhesives, soap, citric acid, methylene blue, methylparaben, propylparaben, chlorhexidine gluconate, isopropyl alcohol, and sodium lauryl sulfate.
- Exposure of the back region to antimicrobial agents, medicated soaps, medicated shampoos, medicated lotions, strong detergents, sun-tanning, use of tanning beds, or swimming or soaking in pools or hot tubs, in the 7 days prior to, or during the 3-week test period.
- Use of topical or systemic corticosteroid, antihistamine, or anti-inflammatory medications in the 7 days prior to, or during the 3-week test period.
- Current or recent severe illness such as asthma, diabetes, hepatitis, 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, breast-feeding
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 |
|---|---|---|
| ChloraprepAlso: Reference Product, 2% Chlorhexidine Gluconate and 70% IPAChloraPrep will be compared to ZuraPrep with regard to skin sensitization and irritation. | Drug | ZuraPrep |
| 0.9% Physiological SalineAlso: Negative Control0.9% Physiological Saline will be compared to ZuraPrep with regard to skin sensitization and irritation. | Drug | ZuraPrep |
| ZuraPrep without IPAAlso: ZuraPrep without Isopropyl Alcohol (IPA)ZuraPrep without IPA will be compared to ZuraPrep with regard to skin sensitization and irritation | Other | ZuraPrep |
Primary outcome
Skin sites evaluated and graded for irritancy or sensitization
Time frame: 0-40 days post dose
Only frank sensitization will be categorized, as a positive control (known sensitizing agent) is prohibitive due to ethical considerations/risk of life-time sensitization. Reactions observed will be assessed as to whether indicative of sensitization or of irritation.
1 secondary outcome
Statistics of irritation scores
Time frame: 0-40 days post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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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.
Maggie Butler, PhD 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?
A Phase 1 study testing Chloraprep, 0.9% Physiological Saline and ZuraPrep without IPA in people with Surgical Site Infection, run by Zurex Pharma, Inc. at 1 site in United States.
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 3 inclusion and 11 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 17 Mar 2015. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Skin sites evaluated and graded for irritancy or sensitization (time frame: 0-40 days post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2015.