Skin Prick Test of KeraStat® Cream
Condition: Hypersensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

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.
    

Intervention name(s): KeraStat® Cream; KeraStat Gel; Biafine; Histamine; Saline (0.9% NaCl)
Intervention type(s): Device; Device; Device; Drug; Drug
Intervention description(s): Administered 0.025 gm of KeraStat Cream per subject on day 1 of the study.; Administered 0.025 gm of KeraStat Gel per subject on day 1 of the study.; Administered 0.025 gm of Biafine per subject on day 1 of the study.; Administered 1 drop of Histamine Dihydrocl (6 mg/mL) per subject on day 1 of the study.; Administered 1 drop of saline per subject on day 1 of the study.
Other intervention name(s): Sodium Chloride syringe
Intervention MeSH terms: Histamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other