ClinicalTrials.gg
Status unknownNCT04526275Updated Nov 19, 2020

Development of Validated Bruise Scale in HNV

An observational study in Bruise, Contusion, sponsored by Cearna, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-19.

Sponsored by Cearna, Inc. · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
27
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Bruise, Contusion

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03

In context

Contusions

43 studies on the registry are indexed under Contusions; 8 are open to participants now.

This study's enrollment of 27 is below the median of 75 across 10 observational studies indexed under Contusions.

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Lead sponsor

Cearna, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy Normal Volunteers

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Fitzpatrick skin type 1-3
  • 25 kg/m2
  • Self described bruisers
  • Intact skin in the target area, free of markings, blemishes and hair

Exclusion criteria

Exclusion Criteria:

  • Use of recreational drugs, , 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
27 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Bruise Healing over time

    Record bruise images over 11 days

    Time frame: 11 days

07

Study locations

1 site
  • Artemis Clinical Research
    San Diego, California 92109, United States
08

References and documents

Individual participant data

Plan to share: No — Aggregate data will be shared and published.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04526275
Lead sponsor
Cearna, Inc.
Responsible party
Sponsor
First posted
Aug 25, 2020
Start date
Sep 25, 2020
Primary completion
Mar 31, 2021 (estimated)
Completion
Apr 28, 2021 (estimated)
Last update
Nov 19, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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