Skin Prick Test of KeraStat® Cream

• Status: Completed
• Trial end date: 2019-08-02
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the potential for a humoral reaction to KeraStat Cream compared to a predicate device using the skin prick test.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: KeraNetics, LLC
• Treatments: Histamine; Histamine phosphate

Criteria

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