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

The objective of this 6 month, interventional, open label prospective pilot study is to
evaluate the effects of a cadexomer iodine gel on the prevention of recurrent keloid
formation in patients undergoing keloid scar revision. Adults 18 years and older with an
established diagnosis of keloid scar formation, scheduled to undergo keloid scar revision
surgery, and who meet the protocol's inclusion and exclusion criteria are eligible for this
study. There will be a minimum of 20 completed subjects with up to 30 enrolled. After keloid
revision surgery, subjects will apply product every other day for one month. There will be a
total of 5 study visits: Visit 0 (Revision Surgery Date and Start of Treatment); Visit 1 (1
Week Post-Revision); Visit 2 (4 Weeks Post-Revision); Visit 3 (12 Weeks Post Revision); and
Visit 4 (24 Weeks Post-Revision and Study Exit). Imaging, Patient and Observer Scar
Assessment Scale questionnaires, and Dermatological Life Quality Index Questions will be
collected. It is hypothesized that there will be a measurable reduction in the amount
(number, size) of keloid formation and/or recurrence at 4, 12, and 24 weeks post revision
surgery time points. The change in subjects' quality of life as measured by the the
Dermatology Quality of Life Index will also be assessed.

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