Development of Validated Bruise Scale in HNV

Bruise, Contusion Clinical Trial

Official title:

Development of a Bruise Scale in Healthy Normal Volunteers

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04526275
• Other study ID #: CI-B002
• Status: Active, not recruiting
• Start date: September 25, 2020
• Est. completion date: April 28, 2021

Study information

• Verified date: November 2020
• Source: Cearna, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 27
• Est. completion date: April 28, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bruise, Contusion
• Contusions
• Ecchymosis

Locations

Country	Name	City	State
United States	Artemis Clinical Research	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Cearna, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bruise Healing over time	Record bruise images over 11 days	11 days