A Phase 2 interventional study of Hydrogel scaffold (MF-4181) in Keloid, sponsored by Halscion, Inc.. Completed at 1 site in Bahamas. Open to participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-03-13.
Sponsored by Halscion, Inc. · Phase 2, Interventional, and Treatment
The objective of the study is to evaluate the initial safety and efficacy of MF-4181, a hydrogel scaffold, in the reduction of the volume, appearance, and/or symptoms associated with keloid scarring in subjects undergoing surgical revision of keloid scars.
138 studies on the registry are indexed under Keloid; 26 are open to participants now.
This study's enrollment of 19 is below 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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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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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.
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Corticosteroids (steroids)
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Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Following surgical removal of the ear keloid, the incision will be treated with MF-4181.
Also known as: Hydrogel scaffold
Device safety
Device safety is defined as the incidence of device related adverse events.
Time frame: 6 months
Device efficacy
Evaluations of cosmesis, induration, erythema and pigmentation will be evaluated by the investigator.
Time frame: 12 months
Device efficacy
Volume and linear measurements will be taken by the investigator
Time frame: 12 months
Device efficacy
Subject evaluation of cosmesis, pain, tenderness, itching and scar satisfaction will be obtained.
Time frame: 12 months
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Halscion, Inc.