Hypersensitivity
Conditions
Brief summary
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.
Interventions
DEVICEKeraStat® Cream
Administered 0.025 gm of KeraStat Cream per subject on day 1 of the study.
DEVICEKeraStat Gel
Administered 0.025 gm of KeraStat Gel per subject on day 1 of the study.
DEVICEBiafine
Administered 0.025 gm of Biafine per subject on day 1 of the study.
DRUGHistamine
Administered 1 drop of Histamine Dihydrocl (6 mg/mL) per subject on day 1 of the study.
DRUGSaline (0.9% NaCl)
Administered 1 drop of saline per subject on day 1 of the study.
Sponsors
KeraNetics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men and women, age 18-65 2. Able to understand the informed consent and provide written informed consent 3. Healthy, unmarked skin at the test area 4. Agreement to avoid consumption of antihistamines until completion of third test reading (Visit 2)
Exclusion criteria
1. Women who are pregnant, lactating/nursing or plan to become pregnant 2. Presence of skin disease, such as widespread urticaria or eczema 3. Diagnosis of infectious disease 4. 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 5. Medical history of hypotension, severe hypertension, vasomotor instability, asthma, autoimmune disease, severe cardiac, pulmonary or renal disease 6. Tattoo in the intrascapular test area 7. History of surgical procedure/skin graft in the intrascapular test area 8. Employee or relative of employee of KeraNetics 9. Consumption of an anti-histamine within 7 days of the screening visit 10. History of hypersensitivity to histamine products 11. Any condition the investigator determines will compromise subject safety or prevent the subject from completing the study 12. Participated in an investigational study within 30 days of the screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reaction to Test Article | assessed at 15 min, 6 hours, 24-48 hours; 15 min reported | Wheal measurement in millimeters (mm) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Main Study Group This study utilized intrasubject comparisons, so each subject received each treatment. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | Main Study Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 22 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 | 0 / 22 |
Outcome results
Primary
Reaction to Test Article
Wheal measurement in millimeters (mm)
Time frame: assessed at 15 min, 6 hours, 24-48 hours; 15 min reported
Population: each unique treatment was applied to a single prick lesion on each participant's back
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KeraStat® Cream | Reaction to Test Article | 0 mm | Standard Deviation 0 |
| KeraStat® Gel | Reaction to Test Article | 0.32 mm | Standard Deviation 1.49 |
| Biafine | Reaction to Test Article | 0.23 mm | Standard Deviation 1.07 |
| Histamine | Reaction to Test Article | 6.73 mm | Standard Deviation 0.34 |
| Saline | Reaction to Test Article | 0 mm | Standard Deviation 0 |