Earlobe KeloidsEURO KLEARNCT01706861
A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid Lesions Treated Adjunctive to Surgical Excision
A study testing Celotres in people with Earlobe Keloids, run by Halscion, Inc. at 6 sites in 3 countries.
Trial summary
The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to reduce the recurrence rate, volume, appearance and/or symptoms associated with keloid scarring in subjects undergoing… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Earlobe Keloids
- What is being tested?
- Celotres
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Sep 2012to May 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients electing to undergo keloid excision procedure
- Patients able and willing to give written informed consent
Who cannot join
- Patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Poland4 sites
Angelius Szpital Proviat
Katowice
Oddzial Leczenia Oparzen Chirugil Plastysznej
Krakow
Kosmetyczno-Lekarska Spółdzielnia Pracy "IZIS"
Warsaw
Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej
Warsaw
The Bahamas1 site
University of the West Indies
Nassau
United Kingdom1 site
The Westbourne Centre
Edgbaston, Birmingham, B15 3SJ
About this study
Official title: A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid LEsions Treated Adjunctive to suRgical Excision. PMCS: EURO-KLEAR
The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to reduce the recurrence rate, volume, appearance and/or symptoms associated with keloid scarring in subjects undergoing surgical excision of keloids as compared to the scientific literature.
- Conditions
- Earlobe Keloids
- Being tested
- Celotres
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CelotresDevice
Celotres following surgical removal of earlobe keloid.
| Study group | Role | What they receive |
|---|---|---|
| Celotres | Other | Celotres following surgical removal of earlobe keloid. Receives: Device: Celotres |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of device related adverse events
Device safety is defined as the incidence of device related adverse events.
Measured: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12
Recurrence of keloid post scar excision
Proportion of subjects with recurrence of keloid scar post excision defined as the presence of scar tissue volume >0.3cc
Measured: Assessed at 1, 3, 6, 9 and 12 months
Secondary outcomes (3)
Patient and Observer Scar Assessment Scale (POSAS)
Measured: Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12
Subject Dermatology Life Quality Index (DLQI)
Measured: Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12
Device Performance Evaluation
Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator.
Measured: Assessed at Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Earlobe KeloidsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halscion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sam Bella, MD, Principal investigator, The Westbourne Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706861
- Sponsor's protocol ID
- HAL-302
- Acronym
- EURO KLEAR
- Status last verified
- Feb 2014
- First submitted
- 3 Oct 2012
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid LEsions Treated Adjunctive to suRgical Excision. PMCS: EURO-KLEAR
- ClinicalTrials.gov ID
- NCT01706861
- Acronym / sponsor ID
- EURO KLEAR / HAL-302
- Conditions
- Earlobe Keloids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Halscion, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Oct 2012 (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.
The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to reduce the recurrence rate, volume, appearance and/or symptoms associated with keloid scarring in subjects undergoing surgical excision of keloids as compared to the scientific literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Celotres | Other | Device: CelotresCelotres following surgical removal of earlobe keloid. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients electing to undergo keloid excision procedure
- Patients able and willing to give written informed consent
Key exclusion criteria (1 listed)
- Patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CelotresCelotres following surgical removal of earlobe keloid. | Device | Celotres |
Primary outcome
The incidence of device related adverse events
Time frame: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12
Device safety is defined as the incidence of device related adverse events.
Recurrence of keloid post scar excision
Time frame: Assessed at 1, 3, 6, 9 and 12 months
Proportion of subjects with recurrence of keloid scar post excision defined as the presence of scar tissue volume >0.3cc
3 secondary outcomes
Patient and Observer Scar Assessment Scale (POSAS)
Time frame: Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12
Subject Dermatology Life Quality Index (DLQI)
Time frame: Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12
Device Performance Evaluation
Time frame: Assessed at Day 1
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 28 May 2014.
Related trials for Earlobe Keloids
Not yet recruitingPhase 2
siRNA Microneedle Patches for Ear Keloid Post-Surgical Scars
Keloid of Ear Lobe
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.
Sam Bella, MD principal investigator
The Westbourne Centre
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celotres in people with Earlobe Keloids, run by Halscion, Inc. at 6 sites in 3 countries.
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 2 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 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Poland, The Bahamas, United Kingdom. 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?
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?
The incidence of device related adverse events (time frame: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12). The study lists 2 primary outcomes in all. 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 28 May 2014.