NCT04058054 is a NA clinical trial of KeraStat® Cream in Hypersensitivity, sponsored by KeraNetics, LLC.

Who is sponsoring NCT04058054?

NCT04058054 is sponsored by KeraNetics, LLC.

What drugs are being tested in NCT04058054?

Interventions in NCT04058054: KeraStat® Cream, KeraStat Gel, Biafine, Histamine, Saline (0.9% NaCl).

What condition does NCT04058054 study?

NCT04058054 studies Hypersensitivity.

Is NCT04058054 still recruiting?

NCT04058054 is currently completed. Last updated 15 November 2022.

Are results published for NCT04058054?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-11-15 · How we verify

NCT04058054

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Skin Prick Test of KeraStat® Cream

Completed NA Results posted Last updated 15 November 2022

What this trial tests

NA trial testing KeraStat® Cream in Hypersensitivity in 22 participants. Completed in 2 August 2019.

Timeline

29 July 2019

Primary endpoint
2 August 2019

2 August 2019

Quick facts

Lead sponsor	KeraNetics, LLC
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	22
Start date	29 July 2019
Primary completion	2 August 2019
Estimated completion	2 August 2019
Sites	1 location across United States

Drugs / interventions tested

KeraStat® Cream
KeraStat Gel
Biafine
Histamine (HISTAMINE) — full drug profile →
Saline (0.9% NaCl) — full drug profile →

Conditions studied

Hypersensitivity — all drugs for Hypersensitivity →

Sponsor

KeraNetics, LLC

Who can join

Adults 18 to 65, any sex, with Hypersensitivity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Reaction to Test Article Primary · assessed at 15 min, 6 hours, 24-48 hours; 15 min reported

Wheal measurement in millimeters (mm)

Group	Value	95% CI
KeraStat® Cream	0	± 0
KeraStat® Gel	0.32	± 1.49
Biafine	0.23	± 1.07
Histamine	6.73	± 0.34
Saline	0	± 0

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Hypersensitivity

Currently open trials in the same condition.

NCT07352813 — Intraosseous vs Infiltration Anesthesia in Molar-Incisor Hypomineralization (MIH) Children · NA · recruiting
NCT06463938 — A Clinical Trial to Compare Lasotronix Alone or in Combination With CPP-ACP to Treat DH · NA · recruiting
NCT00001406 — Activation and Function of Eosinophils in Conditions With Blood or Tissue Eosinophilia · recruiting

Other KeraNetics, LLC trials

Trials by the same sponsor.

NCT03564795 — Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns · NA · terminated
NCT03559218 — KeraStat(R) Cream for Radiation Dermatitis · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04058054 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by KeraNetics, LLC
Last refreshed: 15 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04058054.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing