Skin SensitizationPhase 1NCT01368146
Human Repeat Insult Patch Test of Wound Dressings
A Phase 1 study testing IV Clear™ and Tegaderm CHG™ in people with Skin Sensitization, run by Covalon Technologies Inc. at 1 site in United States.
Trial summary
The purpose of this study is to determine whether contact sensitization occurs to the skin of normal healthy human subjects, by repetitive application of IV Clear™, Tegaderm CHG™ and Silicone Vehicle Control dressings. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Sensitization
- What is being tested?
- IV Clear™ and Tegaderm CHG™
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Apr 2011
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 18 years or older
- In good health, as determined by medical history and concomitant medication
- Able to comprehend and sign informed consent
- Unable to bear children or willing to use adequate birth control
- Willing and able to follow study directions, to participate in the study and to return for all specific visit
Who cannot join
- Subject pregnant, planning a pregnancy or lactating
- Diabetes (any type)
- Mastectomy involving removal of lymph nodes
- Clinically significant skin disease, including but not limited to psoriasis, eczema, atopic dermatitis, and active cancer
- Asthma or other severe respiratory disease requiring medication
- Self-reported immunological disorders including (but not limited to) HIV positive, AIDS, rheumatoid arthritis, and systematic lupus erythematosus
Show all 13Show fewer
- Treatment of any type of cancer within the last two years or history of skin cancer in the test area
- Use of any of the following: topically applied products (e.g. medicals, lotions, creams, etc.) at the application site within 3 days of first application of test articles, immunosuppressive drugs within 30 days of first application of test articles, systemic or topical corticosteroids within 30 days of first application of test articles, and systemic or topically applied anti-inflammatory and antihistamine medications within 3 days of first application of test articles
- Participation in any patch test for irritation or sensitization within the last four weeks
- Participation in any investigational drug study within the last four weeks
- Damaged skin in or around the test sites which includes: sunburn, extremely deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfiguration
- Known sensitization to adhesives, bandages, or materials used in test articles
- Medical condition which, in investigator's judgment, makes the subject ineligible or places the subject at undue risk
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether contact sensitization occurs to the skin of normal healthy human subjects, by repetitive application of IV Clear™, Tegaderm CHG™ and Silicone Vehicle Control dressings.
Read the detailed description
A single center, within-subject randomized study design in healthy adult subjects. Qualified subjects will complete three phases of the study (induction, rest and challenge).
Data for irritation, adhesion and pain upon removal will be collected from the individual patch sites.
- Conditions
- Skin Sensitization
- Being tested
- IV Clear™, Tegaderm CHG™, Silicone Vehicle Control Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Clear™Device
Polyurethane film with a silicone adhesive dressing containing chlorhexidine and silver
Tegaderm CHG™Device
Polyurethane film with a polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate
Silicone Vehicle Control DressingDevice
Polyurethane film with silicone adhesive dressing, without antimicrobials
| Study group | Role | What they receive |
|---|---|---|
| IV Clear™ | Experimental | Not described Receives: Device: IV Clear™ |
| Tegaderm CHG™ | Active comparator | Not described Receives: Device: Tegaderm CHG™ |
| Control Vehicle Dressing | Placebo comparator | Not described Receives: Device: Silicone Vehicle Control Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritation
Irritation assessed at the induction phase will be scored on a Berger and Bowman Scale. Irritation assessed at the challenge phase will be scored on a defined scale measuring erythema reactions, ranging from no reaction to strong erythema.
Measured: Assessed at induction phase (evaluated before reapplication; 9 applications over 3 weeks, reapplied after every 48 or 72 hrs) and challenge phase (single 48-hr application of test article to naive sites and evaluation 30 mins, 24 and 48 hrs post-removal
Secondary outcomes (2)
Adhesion
Adhesion was scored as follows:
0 = no lift from skin (≥90% adherence)
- = some edges only lifting from skin (≥75% to ˂90% adherence)
- = less than half of the test article lifing (≥50% to ˂75% adherence)
- = more than half of the test article lifing but not detached (≥25% to ˂50% adherence)
- = test article detached (0% adherence)
Measured: Assessed at each 72 hour evaluation over three weeks, and once for a single 48-hour challenge application
Pain upon removal
Any pain experienced during removal will be rated on a scale from 0 to 10, where 0 = no pain and 10 = worst possible pain.
Measured: Assessed by subjects at 72 hour evaluations over three weeks and a single 48-hour challenge application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin SensitizationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Covalon Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Micah Humphrey, B.S., Principal investigator, Hill Top Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368146
- Sponsor's protocol ID
- TP-015
- Status last verified
- Feb 2025
- First submitted
- 6 Jun 2011
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Repeat Insult Patch Test of Wound Dressings
- ClinicalTrials.gov ID
- NCT01368146
- Acronym / sponsor ID
- TP-015
- Conditions
- Skin Sensitization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Covalon Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 7 Jun 2011 (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.
The purpose of this study is to determine whether contact sensitization occurs to the skin of normal healthy human subjects, by repetitive application of IV Clear™, Tegaderm CHG™ and Silicone Vehicle Control dressings.
Detailed description
A single center, within-subject randomized study design in healthy adult subjects. Qualified subjects will complete three phases of the study (induction, rest and challenge).
Data for irritation, adhesion and pain upon removal will be collected from the individual patch sites.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IV Clear™ | Experimental | Device: IV Clear™ |
| Tegaderm CHG™ | Active comparator | Device: Tegaderm CHG™ |
| Control Vehicle Dressing | Placebo comparator | Device: Silicone Vehicle Control Dressing |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, 18 years or older
- In good health, as determined by medical history and concomitant medication
- Able to comprehend and sign informed consent
- Unable to bear children or willing to use adequate birth control
- Willing and able to follow study directions, to participate in the study and to return for all specific visit
Key exclusion criteria (13 listed)
- Subject pregnant, planning a pregnancy or lactating
- Diabetes (any type)
- Mastectomy involving removal of lymph nodes
- Clinically significant skin disease, including but not limited to psoriasis, eczema, atopic dermatitis, and active cancer
- Asthma or other severe respiratory disease requiring medication
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 |
|---|---|---|
| IV Clear™Polyurethane film with a silicone adhesive dressing containing chlorhexidine and silver | Device | IV Clear™ |
| Tegaderm CHG™Polyurethane film with a polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate | Device | Tegaderm CHG™ |
| Silicone Vehicle Control DressingPolyurethane film with silicone adhesive dressing, without antimicrobials | Device | Control Vehicle Dressing |
Primary outcome
Irritation
Time frame: Assessed at induction phase (evaluated before reapplication; 9 applications over 3 weeks, reapplied after every 48 or 72 hrs) and challenge phase (single 48-hr application of test article to naive sites and evaluation 30 mins, 24 and 48 hrs post-removal
Irritation assessed at the induction phase will be scored on a Berger and Bowman Scale. Irritation assessed at the challenge phase will be scored on a defined scale measuring erythema reactions, ranging from no reaction to strong erythema.
2 secondary outcomes
Adhesion
Time frame: Assessed at each 72 hour evaluation over three weeks, and once for a single 48-hour challenge application
Pain upon removal
Time frame: Assessed by subjects at 72 hour evaluations over three weeks and a single 48-hour challenge application
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 11 Feb 2025.
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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.
Micah Humphrey, B.S. principal investigator
Hill Top Research
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 IV Clear™ and Tegaderm CHG™ in people with Skin Sensitization, run by Covalon Technologies 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 5 inclusion and 13 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 11 Feb 2025. 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?
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?
Irritation (time frame: Assessed at induction phase (evaluated before reapplication; 9 applications over 3 weeks, reapplied after every 48 or 72 hrs) and challenge phase (single 48-hr application of test article to naive sites and evaluation 30 mins, 24 and 48 hrs post-removal). 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 11 Feb 2025.