Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision

Withdrawn before enrolling · Early Phase 1

Conditions studied: Keloid Scar Following Surgery

In brief

This is a 6 month, single site, interventional, open label prospective clinical study to evaluate the effects of a cadexomer iodine gel on the prevention of recurrent keloid formation in patients undergoing keloid scar revision.

Key facts

Study ID: NCT03876548
Run by: Next Science TM
People needed: 0
Starts: 2019-02-07
Expected to finish: 2019-06-30
Last updated by the study team: 2019-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Each subject must meet the following criteria to be enrolled in this trial:
Male or female 18 years or older
Subject is healthy, as determined by the investigator based on a medical evaluation and history
Subject has an established diagnosis of keloid scar formation
Subject's keloid is on the arm or chest but not on the wrist, elbow, or antecubital fossa
Subject has one or more keloids eligible for scar revision
Subject has a keloid of appropriate size (1 to 2.5 cm in length, 4 to 5 mm in width, and 3 to 4 mm in height)
Subject has no known allergies to study products
Subject is willing and able to avoid total body water exposure from large bodies of water such as pools, lakes, oceans, etc. while using study medication
Subject is willing and able to comply with the requirements of the protocol
Subject is male or non-pregnant, non-lactating woman. Women must be one of the following:
Naturally postmenopausal defined as ≥1 year without menses and:
≥ 55 years or
< 55 years with follicle-stimulating hormone (FSH)≥40.0 IU/L, or
Surgically sterile including hysterectomy, bilateral oophorectomy, and/or tubal ligation, or
Women of childbearing potential willing to use an acceptable method(s) of birth control during the study, while using study medication including:
Oral, topical, injectable, or implantable birth control medications,
Placement of an intrauterine device with or without hormones,
Barrier methods including condoms or occlusive cap with spermicidal foam or spermicidal jelly
Vasectomized male partner who is the sole partner for this patient
True abstinence that is in line with the preferred and usual lifestyle of the patient (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], declaration of abstinence for the duration of the study or withdrawal are not acceptable methods of true abstinence).
There are no protocol-specific birth control requirements for men with partners who are able to become pregnant
Subject has understood and signed an Informed Consent Form

You may not qualify if…

Each subject must meet the following criteria to be enrolled in this trial:
Subject has an underlying known disease, a surgical or medical condition that in the opinion of the investigator might put the subject at risk
Subject's keloid scar is on the wrist, elbow, or antecubital fossa.
Subject is pregnant or breastfeeding at the time of enrollment or is planning to become pregnant at any point during the study period
Subject has a past history of coagulopathy
Subject has an underlying dermatological disease that in the opinion of the investigator could interfere with the study evaluations
Subject is treated with anticoagulants or antiplatelet therapies
Subject has a known allergy or sensitivity to any local anesthetic (such as lidocaine) or a local topical antiseptic that may be used (such as iodine)
Subject has known allergic reaction to the study product
Subject has a known history of shellfish allergy or sensitivity
Subject has known history of Hashimoto's Thyroiditis, Graves' disease, a thyroid disorder, a non-toxic goiter
Subject is taking Lithium, Sulphafurazoles or Sulphonylureas
Subject is prone to Vasovagal syncope
Subject is unable to provide signed and dated informed consent form

Where it is running

Jacksonville Center for Clinical Research — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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