Development of Validated Bruise Scale in HNV

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-25

Study Completion Date

2021-04-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bruise, Contusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Artemis Clinical Research

San Diego, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CI-B002

Identifier Type: -

Identifier Source: org_study_id