Skin Prick Test of KeraStat® Cream

NCT04058054 | Completed Results DMC FDA Device

• 1 other identifier: KSCM-CRD-002
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Reaction to Test Article

  Wheal measurement in millimeters (mm)

  assessed at 15 min, 6 hours, 24-48 hours; 15 min reported

Study Arms (5)

KeraStat® Cream

EXPERIMENTAL

KeraStat® Cream is a non-sterile, non-implantable wound dressing intended to provide a moist environment in the management of a variety of partial thickness dermal wounds.

Device: KeraStat® Cream

KeraStat® Gel

EXPERIMENTAL

KeraStat® Gel is a sterile, non-implantable water-based gelatinous (hydrogel) wound dressing intended to act as a protective covering in the management of a variety of partial thickness dermal wounds.

Device: KeraStat Gel

Biafine

EXPERIMENTAL

Wound dressing for management of partial and full thickness wounds.

Device: Biafine

Histamine

ACTIVE COMPARATOR

Histamine is provided as a solution of histamine base (6.0 mg/mL).

Drug: Histamine

Saline

SHAM COMPARATOR

Saline (sterile) is provided as a 0.9% NaCl solution.

Drug: Saline (0.9% NaCl)

Interventions

KeraStat® Cream DEVICE

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

KeraStat® Cream

KeraStat Gel DEVICE

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

KeraStat® Gel

Biafine DEVICE

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

Biafine

Histamine DRUG

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

Histamine

Saline (0.9% NaCl) DRUG

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

Also known as: Sodium Chloride syringe

Saline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• KeraNetics, LLC: lead

Study Sites (1)

PMG Research, Inc.

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Hypersensitivity

Interventions

Histamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Ethylamines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Autacoids; Inflammation Mediators; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Chris Holder, PhD
• Organization: KeraNetics, Inc.

cholder@keranetics.com

336-413-3393

Study Officials

• Jonathan P Wilson, DO

  PMG Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 15, 2019
• Study Start: July 29, 2019
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: November 15, 2022
• Results First Posted: September 15, 2022

Record last verified: 2022-10

Locations

US (1)