Development of Validated Bruise Scale in HNV

Development of a Bruise Scale in Healthy Normal Volunteers

Subjects will have a mechanically induced bruise photographed over a period of 11 days to record the healing process. Assessors will rate the bruises to develop a bruising scale.

Study Overview

• Status: Unknown
• Conditions: Bruise, Contusion

Detailed Description

Observational study. Healthy normal volunteers will come into the clinic and have a bruise induced. The bruised area will be photographed each day through Day 11. Images will be provided to the Validator Team to rate on a 0-5 scale of severity.

The actual numbers of volunteers will be adjusted to ensure there are at least 15 images for each Grade.

The clinical site will be provided photography equipment, and study staff will be trained on photography technique to standardize the image quality and resolution across the study.

The Validator Team will review the images and categorize them in to Grades 0-5.

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92109
      • Artemis Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Healthy Normal Volunteers

Description

Inclusion Criteria:

• Fitzpatrick skin type 1-3
• BMI 25 kg/m2
• Self described bruisers
• Intact skin in the target area, free of markings, blemishes and hair

Exclusion Criteria:

• Use of recreational drugs, steroids, pain medications, other homeopathic remedies, anticoagulant therapies, antiplatelet therapy
• Known history of dermal sensitivity, serious illness, hematological abnormality, impaired wound healing
• Inability to forego application of topical products in the target area
• Hair removal by laser, wax or chemicals within one week prior to Day 1
• Avoid tanning beds
• Active wound or infection in the target area
• History of keloids or hypertrophic scarring
• History of collagen or vascular disease
• History of organ transplant

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bruise Healing over time	Record bruise images over 11 days	11 days

Collaborators and Investigators

• Sponsor: Cearna, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2020
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): April 28, 2021

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: August 21, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): November 19, 2020
• Last Update Submitted That Met QC Criteria: November 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Hematologic Diseases; Hemorrhage; Blood Coagulation Disorders; Skin Manifestations; Wounds, Nonpenetrating; Ecchymosis; Contusions
• Other Study ID Numbers: CI-B002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Aggregate data will be shared and published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No