Status:
COMPLETED
Skin Prick Test of KeraStat® Cream
Lead Sponsor:
KeraNetics, LLC
Conditions:
Hypersensitivity
Eligibility:
All Genders
18-65 years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04058054
Start Date
July 29 2019
End Date
August 2 2019
Last Update
November 15 2022
Active Locations (1)
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1
PMG Research, Inc.
Winston-Salem, North Carolina, United States, 27103