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

Earlobe Keloids Clinical Trial

— EURO KLEAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01706861
• Other study ID #: HAL-302
• Status: Completed
• Phase: N/A
• First received: October 3, 2012
• Last updated: May 24, 2014
• Start date: September 2012
• Est. completion date: May 2014

Study information

• Verified date: February 2014
• Source: Halscion, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServicesPoland: Ethic Committee
• Study type: Interventional

Clinical 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 surgical excision of keloids as compared to the scientific literature.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Earlobe Keloids
• Keloid

Intervention

Device:
• Celotres
Celotres following surgical removal of earlobe keloid.

Locations

Country	Name	City	State
Bahamas	University of the West Indies	Nassau
Poland	Angelius Szpital Proviat	Katowice
Poland	Oddzial Leczenia Oparzen Chirugil Plastysznej	Krakow
Poland	Kosmetyczno-Lekarska Spóldzielnia Pracy "IZIS"	Warsaw
Poland	Wojskowy Oddzial Kliniczny ChirurgiiPlastycznej	Warsaw
United Kingdom	The Westbourne Centre	Edgbaston	Birmingham

Sponsors (1)

Lead Sponsor	Collaborator
Halscion, Inc.

Countries where clinical trial is conducted

Bahamas,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of device related adverse events	Device safety is defined as the incidence of device related adverse events.	Assessed at treatment, suture removal, Months 1, 3, 6, 9 and 12	Yes
Primary	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	Assessed at 1, 3, 6, 9 and 12 months	No
Secondary	Patient and Observer Scar Assessment Scale (POSAS)		Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12	No
Secondary	Subject Dermatology Life Quality Index (DLQI)		Assessed at Pre-treatment, Months 1, 3, 6, 9 and 12	No
Secondary	Device Performance Evaluation	Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator.	Assessed at Day 1	No