Trial Outcomes & Findings for Skin Prick Test of KeraStat® Cream (NCT NCT04058054)

Last Updated: 2022-11-15

Results Overview

Wheal measurement in millimeters (mm)

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

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

Results posted on

2022-11-15

Unit of analysis: Skin prick site

Participant milestones
Measure	KeraStat® Cream 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. KeraStat® Cream: Administered 0.025 gm of KeraStat Cream per subject on day 1 of the study.	KeraStat® Gel 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. KeraStat Gel: Administered 0.025 gm of KeraStat Gel per subject on day 1 of the study.	Biafine Wound dressing for management of partial and full thickness wounds. Biafine: Administered 0.025 gm of Biafine per subject on day 1 of the study.	Histamine Histamine is provided as a solution of histamine base (6.0 mg/mL). Histamine: Administered 1 drop of Histamine Dihydrocl (6 mg/mL) per subject on day 1 of the study.	Saline Saline (sterile) is provided as a 0.9% NaCl solution. Saline (0.9% NaCl): Administered 1 drop of saline per subject on day 1 of the study.
Overall Study STARTED	22 22	22 22	22 22	22 22	22 22
Overall Study COMPLETED	22 22	22 22	22 22	22 22	22 22
Overall Study NOT COMPLETED	0 0	0 0	0 0	0 0	0 0

Withdrawal data not reported

Skin Prick Test of KeraStat® Cream

Baseline characteristics by cohort
Measure	Main Study Group n=22 Participants This study utilized intrasubject comparisons, so each subject received each treatment.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants

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

Population: each unique treatment was applied to a single prick lesion on each participant's back

Wheal measurement in millimeters (mm)