Development of Validated Bruise Scale in HNV

Cearna, Inc.27 enrolled

Overview

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.

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

Conditions

Bruise, Contusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Artemis Clinical Research

San Diego, California, United States

Outcomes

Primary Outcomes

Bruise Healing over time

Record bruise images over 11 days

Time frame: 11 days

Data from ClinicalTrials.gov

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