Development of Validated Bruise Scale in HNV
- Conditions
- Bruise, Contusion
- Registration Number
- NCT04526275
- Lead Sponsor
- Cearna, Inc.
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 27
- Fitzpatrick skin type 1-3
- BMI 25 kg/m2
- Self described bruisers
- Intact skin in the target area, free of markings, blemishes and hair
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bruise Healing over time 11 days Record bruise images over 11 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Artemis Clinical Research
🇺🇸San Diego, California, United States