N/A
N=110
Skin Prick Test of KeraStat® Cream
Hypersensitivity
Bottom Line
View on ClinicalTrials.gov: NCT04058054 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Reaction to Test Article — 0; 0.32; 0.23; 6.73 mm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- KeraStat® Cream (Device); KeraStat Gel (Device); Biafine (Device); Histamine (Drug); Saline (0.9% NaCl) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- KeraNetics, LLC
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reaction to Test Article |
0; 0.32; 0.23; 6.73; 0 | — |
Summary
To evaluate the potential for a humoral reaction to KeraStat Cream compared to a predicate device using the skin prick test.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04058054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.