Development of Validated Bruise Scale in HNV

Cearna

Status: Unknown

Conditions: Bruise, Contusion

Study type: Observational

Funder types: Industry

Identifiers

NCT04526275

CI-B002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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