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

Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision: A Pilot Clinical Study

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.

Study Overview

• Status: Withdrawn
• Conditions: Keloid Scar Following Surgery
• Intervention / Treatment: Device: Cadexomer Iodine Gel

Detailed Description

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.

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cadexomer Iodine Gel; Patients willy apply product to treatment site every other day for the next 28 days and cover with dressing or bandage.	Device: Cadexomer Iodine Gel; Subjects will apply gel product to keloid scar site every other day for 28 days following keloid scar revision surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar measurement with Silhouette Camera Imaging	The keloid or keloid scar will measured using the Silhouette Camera Imaging System	24 weeks
Patient and Observer Scar Assessment Scale (Subject facing)	Patient and Observer Scar Assessment to be completed by the subject with the physician.	24 weeks
Patient and Observer Scar Assessment Scale (Non-Subject facing)	Patient and Observer Scar Assessment to be completed by the physician only.	24 weeks
Response Rate calculation	Response Rate calculation = Complete Remission + Partial Response (RR= CR + PR)	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatology Quality of Life Index	Dermatology Quality of Life Index Questionaire	24 Weeks

Collaborators and Investigators

• Sponsor: Next Science TM
• Collaborators: Jacksonville Center For Clinical Research
• Investigators: Principal Investigator: Michael Bernhardt, MD, Jacksonville Center for Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2019
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: March 12, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 26, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: keloid
• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Fibrosis; Cicatrix; Collagen Diseases; Keloid; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Trace Elements; Micronutrients; Iodine; Cadexomer iodine
• Other Study ID Numbers: CSP-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No