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

This is an interventional prevention trial for Keloid Scar Following Surgery focused on measuring keloid Read More

Inclusion Criteria:

Each subject must meet the following criteria to be enrolled in this trial:

1. Male or female 18 years or older
2. Subject is healthy, as determined by the investigator based on a medical evaluation and history
3. Subject has an established diagnosis of keloid scar formation
4. Subject's keloid is on the arm or chest but not on the wrist, elbow, or antecubital fossa
5. Subject has one or more keloids eligible for scar revision
6. 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)
7. Subject has no known allergies to study products
8. 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
9. Subject is willing and able to comply with the requirements of the protocol

10. 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
11. Subject has understood and signed an Informed Consent Form

Exclusion Criteria:

Each subject must meet the following criteria to be enrolled in this trial:

1. Subject has an underlying known disease, a surgical or medical condition that in the opinion of the investigator might put the subject at risk
2. Subject's keloid scar is on the wrist, elbow, or antecubital fossa.
3. Subject is pregnant or breastfeeding at the time of enrollment or is planning to become pregnant at any point during the study period
4. Subject has a past history of coagulopathy
5. Subject has an underlying dermatological disease that in the opinion of the investigator could interfere with the study evaluations
6. Subject is treated with anticoagulants or antiplatelet therapies
7. 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)
8. Subject has known allergic reaction to the study product
9. Subject has a known history of shellfish allergy or sensitivity
10. Subject has known history of Hashimoto's Thyroiditis, Graves' disease, a thyroid disorder, a non-toxic goiter
11. Subject is taking Lithium, Sulphafurazoles or Sulphonylureas
12. Subject is prone to Vasovagal syncope
13. Subject is unable to provide signed and dated informed consent form