MedTrace Logo

Skin Prick Test of KeraStat® Cream

NCT04058054 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-11-15

Study results available
· View outcomes & findings →

Summary

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

Conditions

Interventions

DEVICE

KeraStat® Cream

Administered 0.025 gm of KeraStat Cream per subject on day 1 of the study.

DEVICE

KeraStat Gel

Administered 0.025 gm of KeraStat Gel per subject on day 1 of the study.

DEVICE

Biafine

Administered 0.025 gm of Biafine per subject on day 1 of the study.

DRUG

Histamine

Administered 1 drop of Histamine Dihydrocl (6 mg/mL) per subject on day 1 of the study.

DRUG

Saline (0.9% NaCl)

Administered 1 drop of saline per subject on day 1 of the study.

Sponsors & Collaborators

  • KeraNetics, LLC

    lead INDUSTRY

Principal Investigators

  • Jonathan P Wilson, DO · PMG Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-29
Primary Completion
2019-08-02
Completion
2019-08-02
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04058054 on ClinicalTrials.gov