An interventional study of Celotres in Earlobe Keloids, sponsored by Halscion, Inc.. Completed at 6 sites in 3 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-28.
Sponsored by Halscion, Inc. · Not applicable, Interventional, and Treatment
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.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's enrollment of 51 is above the median of 30 across 109 interventional studies indexed under Keloid.
Browse Keloid studies →Halscion, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Celotres following surgical removal of earlobe keloid.
Device: Celotres
Celotres following surgical removal of earlobe keloid.
The incidence of device related adverse events
Device safety is defined as the incidence of device related adverse events.
Time frame: 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
Time frame: Assessed at 1, 3, 6, 9 and 12 months
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
Questions related to packaging integrity and successful administration of product as assessed by the Principal Investigator.
Time frame: Assessed at Day 1
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Halscion, Inc.