SteatoblepharonNCT02609763
Live Validation of the Lower Eyelid Steatoblepharon Severity (LESS) Scale
An observational study of Steatoblepharon, run by Topokine Therapeutics, Inc..
Trial summary
This observational study will test the inter-rater and test-retest reliability of the LESS scale in a live context. Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Steatoblepharon
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2015
- 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 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible adults with varying degrees of lower eyelid steatoblepharon
Who may be able to join
- Must provide informed consent
Who cannot join
- Unable or unwilling to complete study procedures
About this study
This observational study will test the inter-rater and test-retest reliability of the LESS scale in a live context.
- Conditions
- Steatoblepharon
What is being measured
The primary outcome is the main question the study is designed to answer.
LESS score (Clinician-Reported)
Measured: Eyelids will be assessed on one day only (cross-sectional study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SteatoblepharonStudies 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
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topokine Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02609763
- Sponsor's protocol ID
- TPK-SCALE-03
- Status last verified
- Nov 2015
- First submitted
- 16 Nov 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Live Validation of the Lower Eyelid Steatoblepharon Severity (LESS) Scale
- ClinicalTrials.gov ID
- NCT02609763
- Acronym / sponsor ID
- TPK-SCALE-03
- Conditions
- Steatoblepharon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Topokine Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Nov 2015 (estimated)
- 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.
This observational study will test the inter-rater and test-retest reliability of the LESS scale in a live context.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible adults with varying degrees of lower eyelid steatoblepharon
Key inclusion criteria (1 listed)
- Must provide informed consent
Key exclusion criteria (1 listed)
- Unable or unwilling to complete study procedures
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
LESS score (Clinician-Reported)
Time frame: Eyelids will be assessed on one day only (cross-sectional study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Steatoblepharon, run by Topokine Therapeutics, Inc..
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
LESS score (Clinician-Reported) (time frame: Eyelids will be assessed on one day only (cross-sectional study)). 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 2 Dec 2015.