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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Halscion, Inc.
ClinicalTrials.gov Identifier:
NCT01706861
First received: October 3, 2012
Last updated: May 24, 2014
Last verified: February 2014
  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.


Enrollment: 51
Study Start Date: September 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706861

Locations
Bahamas
University of the West Indies
Nassau, Bahamas
Poland
Angelius Szpital Proviat
Katowice, Poland
Oddzial Leczenia Oparzen Chirugil Plastysznej
Krakow, Poland
Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej
Warsaw, Poland
Kosmetyczno-Lekarska Spółdzielnia Pracy "IZIS"
Warsaw, Poland
United Kingdom
The Westbourne Centre
Edgbaston, Birmingham, United Kingdom, B15 3SJ
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: May 24, 2014
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 July 24, 2014