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 (EURO KLEAR)
This study is currently recruiting participants.
Verified March 2013 by Halscion, Inc.
Sponsor:
Halscion, Inc.
Information provided by (Responsible Party):
Halscion, Inc.
ClinicalTrials.gov Identifier:
NCT01706861
First received: October 3, 2012
Last updated: March 28, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Earlobe Keloids |
Device: Celotres |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Halscion, Inc.:
Primary Outcome Measures:
- The incidence of device related adverse events [ Time Frame: Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]Proportion of subjects with recurrence of keloid scar post excision defined as the presence of scar tissue volume >0.3cc
Secondary Outcome Measures:
- Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
- Subject Dermatology Life Quality Index (DLQI) [ Time Frame: Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
- Device Performance Evaluation [ Time Frame: Assessed at Day 1 ] [ Designated as safety issue: No ]Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator.
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Celotres
Celotres following surgical removal of earlobe keloid.
|
Device: Celotres
Celotres following surgical removal of earlobe keloid.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients electing to undergo keloid excision procedure
- Patients able and willing to give written informed consent
Exclusion Criteria:
- Patients with a known or potential risk of allergy or sensitivity to products or substances containing porcine gelatin.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706861
Contacts
| Contact: Andrew Green | 6785345950 | dgreen@halscion.net |
Locations
| Bahamas | |
| University of the West Indies | Recruiting |
| Nassau, Bahamas | |
| Contact: Srikanth Garikaparthi, MD | |
| Principal Investigator: Srikanth Garikaparthi, MD | |
| Poland | |
| Angelius Szpital Proviat | Recruiting |
| Katowice, Poland | |
| Contact: Zbigniew Lucki, MD | |
| Principal Investigator: Zbigniew Lucki, MD | |
| Oddzial Leczenia Oparzen Chirugil Plastysznej | Recruiting |
| Krakow, Poland | |
| Contact: Kazimierz Cieslik, MD | |
| Principal Investigator: Kazimierz Cieszlik, MD | |
| Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej | Recruiting |
| Warsaw, Poland | |
| Contact: Wojciech Witkowski, MD | |
| Principal Investigator: Wojciech Witkowski, MD | |
| Kosmetyczno-Lekarska Spółdzielnia Pracy "IZIS" | Recruiting |
| Warsaw, Poland | |
| Contact: Mariusz Szabela, MD | |
| Principal Investigator: Mariusz Szabela, MD | |
| United Kingdom | |
| The Westbourne Centre | Recruiting |
| Edgbaston, Birmingham, United Kingdom, B15 3SJ | |
| Contact: Sam Bella, MD | |
| Principal Investigator: Sam Bella, MD | |
Sponsors and Collaborators
Halscion, Inc.
Investigators
| Principal Investigator: | Sam Bella, MD | The Westbourne Centre |
More Information
No publications provided
| Responsible Party: | Halscion, Inc. |
| ClinicalTrials.gov Identifier: | NCT01706861 History of Changes |
| Other Study ID Numbers: | HAL-302 |
| Study First Received: | October 3, 2012 |
| Last Updated: | March 28, 2013 |
| Health Authority: | United Kingdom: National Health Services Poland: Ethic Committee |
Additional relevant MeSH terms:
|
Keloid Recurrence Collagen Diseases Connective Tissue Diseases |
Cicatrix Fibrosis Pathologic Processes Disease Attributes |
ClinicalTrials.gov processed this record on May 19, 2013