Skin Prick Test of KeraStat® Cream

Not Applicable

Completed

Conditions: Hypersensitivity

Interventions: Device: Biafine
Device: KeraStat Gel
Drug: Saline (0.9% NaCl)
Device: KeraStat® Cream
Drug: Histamine

Registration Number: NCT04058054

Lead Sponsor: KeraNetics, LLC

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 22

Inclusion Criteria

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)

Exclusion Criteria

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
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biafine	Biafine	Wound dressing for management of partial and full thickness wounds.
KeraStat® Gel	KeraStat Gel	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.
Saline	Saline (0.9% NaCl)	Saline (sterile) is provided as a 0.9% NaCl solution.
KeraStat® Cream	KeraStat® Cream	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.
Histamine	Histamine	Histamine is provided as a solution of histamine base (6.0 mg/mL).