Bruise, ContusionNCT04526275
Development of Validated Bruise Scale in HNV
An observational study of Bruise, Contusion, run by Cearna, Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bruise, Contusion
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2020to 28 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Normal Volunteers
Who may be able to join
- Fitzpatrick skin type 1-3
- BMI 25 kg/m2
- Self described bruisers
- Intact skin in the target area, free of markings, blemishes and hair
Who cannot join
- 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
Show all 9Show fewer
- History of keloids or hypertrophic scarring
- History of collagen or vascular disease
- History of organ transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
Artemis Clinical Research
San Diego, California, 92109
About this study
Official title: Development of a Bruise Scale in Healthy Normal Volunteers
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.
- Conditions
- Bruise, Contusion
- Medical subject headings
- Contusions
What is being measured
The primary outcome is the main question the study is designed to answer.
Bruise Healing over time
Record bruise images over 11 days
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start25 Sep 2020
- Primary completion31 Mar 2021 (estimated)
- Study completion28 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bruise, ContusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cearna, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526275
- Sponsor's protocol ID
- CI-B002
- Status last verified
- Nov 2020
- First submitted
- 21 Aug 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregate data will be shared and published.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Bruise Scale in Healthy Normal Volunteers
- ClinicalTrials.gov ID
- NCT04526275
- Acronym / sponsor ID
- CI-B002
- Conditions
- Bruise, Contusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Cearna, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 28 Apr 2021 (estimated)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Normal Volunteers
Key inclusion criteria (4 listed)
- Fitzpatrick skin type 1-3
- BMI 25 kg/m2
- Self described bruisers
- Intact skin in the target area, free of markings, blemishes and hair
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bruise Healing over time
Time frame: 11 days
Record bruise images over 11 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
- Individual participant dataSharing planned: No. Aggregate data will be shared and published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bruise, Contusion, run by Cearna, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bruise Healing over time (time frame: 11 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2020.