HypersensitivityNCT04058054
Skin Prick Test of KeraStat® Cream
A study testing KeraStat® Cream, KeraStat Gel and Biafine in people with Hypersensitivity, run by KeraNetics, LLC at 1 site in United States.
Trial summary
To evaluate the potential for a humoral reaction to KeraStat Cream compared to a predicate device using the skin prick test. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypersensitivity
- What is being tested?
- KeraStat® Cream, KeraStat Gel and Biafine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2019to 2 Aug 2019
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women, age 18-65
- Able to understand the informed consent and provide written informed consent
- Healthy, unmarked skin at the test area
- Agreement to avoid consumption of antihistamines until completion of third test reading (Visit 2)
Who cannot join
- Women who are pregnant, lactating/nursing or plan to become pregnant
- Presence of skin disease, such as widespread urticaria or eczema
- Diagnosis of infectious disease
- Receiving corticosteroids, immunosuppressive agents, radiation or chemotherapy, topical growth factors, anxiolytics, imipramine, phenothiazine, dopamine, phenergen, clonidine, montelukast, immunotherapy, UV light therapy, H-2 antagonist, cyclosporine or any other medication the investigator feels will affect the test within the last month
- Medical history of hypotension, severe hypertension, vasomotor instability, asthma, autoimmune disease, severe cardiac, pulmonary or renal disease
- Tattoo in the intrascapular test area
Show all 12Show fewer
- History of surgical procedure/skin graft in the intrascapular test area
- Employee or relative of employee of KeraNetics
- Consumption of an anti-histamine within 7 days of the screening visit
- History of hypersensitivity to histamine products
- Any condition the investigator determines will compromise subject safety or prevent the subject from completing the study
- Participated in an investigational study within 30 days of the screening visit
Trial locations and contacts
1 site in 1 country.
United States1 site
PMG Research, Inc.
Winston-Salem, North Carolina, 27103
About this study
To evaluate the potential for a humoral reaction to KeraStat Cream compared to a predicate device using the skin prick test.
Read the detailed description
Study Overview:
Study Periods:
The length of study participation for a subject is about 2-3 days depending on availability for the final site check. There are two skin prick site checks during the course of Day 1 with a final follow up between Days 2 and 3.
Study Evaluations:
Initial screening (Screening Visit; Visit 1) will be performed on the day of the Skin Prick Test (SPT) administration and will include obtaining demographic information, brief medical history, and abbreviated physical exam.
On Day 1 (Visit 1) the SPT will be performed on the infrascapular region of the back to the right of the midline. Test articles will include the subject device (KeraStat Cream), predicate devices (KeraStat Gel, Biafine), positive control (histamine), and negative control (saline). Each test article will have a single administration, only the re-test will utilize a triplicate administration. The SPT will be ready for initial reading after approximately 15 minutes (but no sooner than 10 minutes and no longer than 20 minutes) following the final SPT administration in the series. When reading the test, the investigator will note the presence or absence of a wheal at all five sites and will measure the diameter of each wheal present. In order for the SPT to be valid, the wheal at the positive control site must exceed that at the negative control by 4 mm. If the above criteria are not met, the SPT will be repeated in triplicate on the infrascapular region of the back to the left of the midline, following the same protocol. Following the initial reading, the subject will remain at the testing facility.
A second reading will be conducted approximately 6 hours (+/- 15 minutes) after SPT administration on Day 1 (Visit 1). When reading the test, the investigator will note the presence or absence of a wheal at all five sites and will measure the diameter of each wheal present. Subjects are free to leave the clinical site after the second reading. Subjects will be instructed to promptly contact the PI and go to the ER if symptoms of an allergic reaction or shock occur.
Subjects will return to the office one to two days after initial administration for a third test reading (Visit 2). When reading the test, the investigator will note the presence or absence of a wheal in all five sites and will measure the diameter of each wheal present. Each site of test article administration will be measured for a positive reaction. A positive reaction is present when there is a measurable wheal of 3 mm or more, surrounded by a flare. Small wheals are to be confirmed by palpation. A flare alone is disregarded.
- Conditions
- Hypersensitivity
- Being tested
- KeraStat® Cream, KeraStat Gel, Biafine, Histamine, Saline (0.9% NaCl)
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeraStat® CreamDevice
Administered 0.025 gm of KeraStat Cream per subject on day 1 of the study.
KeraStat GelDevice
Administered 0.025 gm of KeraStat Gel per subject on day 1 of the study.
BiafineDevice
Administered 0.025 gm of Biafine per subject on day 1 of the study.
HistamineDrug
Administered 1 drop of Histamine Dihydrocl (6 mg/mL) per subject on day 1 of the study.
Saline (0.9% NaCl)Drug
Also called Sodium Chloride syringe
Administered 1 drop of saline per subject on day 1 of the study.
| Study group | Role | What they receive |
|---|---|---|
| KeraStat® Cream | Experimental | KeraStat® Cream is a non-sterile, non-implantable wound dressing intended to provide a moist environment in the management of a variety of partial thickness dermal wounds. Receives: Device: KeraStat® Cream |
| KeraStat® Gel | Experimental | KeraStat® Gel is a sterile, non-implantable water-based gelatinous (hydrogel) wound dressing intended to act as a protective covering in the management of a variety of partial thickness dermal wounds. Receives: Device: KeraStat Gel |
| Biafine | Experimental | Wound dressing for management of partial and full thickness wounds. Receives: Device: Biafine |
| Histamine | Active comparator | Histamine is provided as a solution of histamine base (6.0 mg/mL). Receives: Drug: Histamine |
| Saline | Sham comparator | Saline (sterile) is provided as a 0.9% NaCl solution. Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction to Test Article
Wheal measurement in millimeters (mm)
Measured: assessed at 15 min, 6 hours, 24-48 hours; 15 min reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start29 Jul 2019
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
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 HypersensitivityStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- KeraNetics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan P Wilson, DO, Principal investigator, PMG Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058054
- Sponsor's protocol ID
- KSCM-CRD-002
- Status last verified
- Oct 2022
- First submitted
- 14 Aug 2019
- Last updated
- 15 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Prick Test of KeraStat® Cream
- ClinicalTrials.gov ID
- NCT04058054
- Acronym / sponsor ID
- KSCM-CRD-002
- Conditions
- Hypersensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- KeraNetics, LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 15 Aug 2019 (actual)
- Results
- Posted 15 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the potential for a humoral reaction to KeraStat Cream compared to a predicate device using the skin prick test.
Detailed description
Study Overview:
Study Periods:
The length of study participation for a subject is about 2-3 days depending on availability for the final site check. There are two skin prick site checks during the course of Day 1 with a final follow up between Days 2 and 3.
Study Evaluations:
Initial screening (Screening Visit; Visit 1) will be performed on the day of the Skin Prick Test (SPT) administration and will include obtaining demographic information, brief medical history, and abbreviated physical exam.
On Day 1 (Visit 1) the SPT will be performed on the infrascapular region of the back to the right of the midline. Test articles will include the subject device (KeraStat Cream), predicate devices (KeraStat Gel, Biafine), positive control (histamine), and negative control (saline). Each test article will have a single administration, only the re-test will utilize a triplicate administration. The SPT will be ready for initial reading after approximately 15 minutes (but no sooner than 10 minutes and no longer than 20 minutes) following the final SPT administration in the series. When reading the test, the investigator will note the presence or absence of a wheal at all five sites and will measure the diameter of each wheal present. In order for the SPT to be valid, the wheal at the positive control site must exceed that at the negative control by 4 mm. If the above criteria are not met, the SPT will be repeated in triplicate on the infrascapular region of the back to the left of the midline, following the same protocol. Following the initial reading, the subject will remain at the testing facility.
A second reading will be conducted approximately 6 hours (+/- 15 minutes) after SPT administration on Day 1 (Visit 1). When reading the test, the investigator will note the presence or absence of a wheal at all five sites and will measure the diameter of each wheal present. Subjects are free to leave the clinical site after the second reading. Subjects will be instructed to promptly contact the PI and go to the ER if symptoms of an allergic reaction or shock occur.
Subjects will return to the office one to two days after initial administration for a third test reading (Visit 2). When reading the test, the investigator will note the presence or absence of a wheal in all five sites and will measure the diameter of each wheal present. Each site of test article administration will be measured for a positive reaction. A positive reaction is present when there is a measurable wheal of 3 mm or more, surrounded by a flare. Small wheals are to be confirmed by palpation. A flare alone is disregarded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| KeraStat® Cream | Experimental | Device: KeraStat® CreamKeraStat® Cream is a non-sterile, non-implantable wound dressing intended to provide a moist environment in the management of a variety of partial thickness dermal wounds. |
| KeraStat® Gel | Experimental | Device: KeraStat GelKeraStat® Gel is a sterile, non-implantable water-based gelatinous (hydrogel) wound dressing intended to act as a protective covering in the management of a variety of partial thickness dermal wounds. |
| Biafine | Experimental | Device: BiafineWound dressing for management of partial and full thickness wounds. |
| Histamine | Active comparator | Drug: HistamineHistamine is provided as a solution of histamine base (6.0 mg/mL). |
| Saline | Sham comparator | Drug: Saline (0.9% NaCl)Saline (sterile) is provided as a 0.9% NaCl solution. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women, age 18-65
- Able to understand the informed consent and provide written informed consent
- Healthy, unmarked skin at the test area
- Agreement to avoid consumption of antihistamines until completion of third test reading (Visit 2)
Key exclusion criteria (12 listed)
- Women who are pregnant, lactating/nursing or plan to become pregnant
- Presence of skin disease, such as widespread urticaria or eczema
- Diagnosis of infectious disease
- Receiving corticosteroids, immunosuppressive agents, radiation or chemotherapy, topical growth factors, anxiolytics, imipramine, phenothiazine, dopamine, phenergen, clonidine, montelukast, immunotherapy, UV light therapy, H-2 antagonist, cyclosporine or any other medication the investigator feels will affect the test within the last month
- Medical history of hypotension, severe hypertension, vasomotor instability, asthma, autoimmune disease, severe cardiac, pulmonary or renal disease
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 |
|---|---|---|
| KeraStat® CreamAdministered 0.025 gm of KeraStat Cream per subject on day 1 of the study. | Device | KeraStat® Cream |
| KeraStat GelAdministered 0.025 gm of KeraStat Gel per subject on day 1 of the study. | Device | KeraStat® Gel |
| BiafineAdministered 0.025 gm of Biafine per subject on day 1 of the study. | Device | Biafine |
| HistamineAdministered 1 drop of Histamine Dihydrocl (6 mg/mL) per subject on day 1 of the study. | Drug | Histamine |
| Saline (0.9% NaCl)Also: Sodium Chloride syringeAdministered 1 drop of saline per subject on day 1 of the study. | Drug | Saline |
Primary outcome
Reaction to Test Article
Time frame: assessed at 15 min, 6 hours, 24-48 hours; 15 min reported
Wheal measurement in millimeters (mm)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jonathan P Wilson, DO principal investigator
PMG Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KeraStat® Cream, KeraStat Gel and Biafine in people with Hypersensitivity, run by KeraNetics, LLC 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 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 15 Nov 2022. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2022). 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?
Reaction to Test Article (time frame: assessed at 15 min, 6 hours, 24-48 hours; 15 min reported). 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 15 Nov 2022.