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

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ClinicalTrials.gov Identifier: NCT03876548
Recruitment Status : Recruiting
First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
Jacksonville Center For Clinical Research
Information provided by (Responsible Party):
Next Science TM

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Keloid Scar Following Surgery Device: Cadexomer Iodine Gel Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Prevention
Official Title: Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision: A Pilot Clinical Study
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
Drug Information available for: Iodine

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.




Primary Outcome Measures :
  1. Scar measurement with Silhouette Camera Imaging [ Time Frame: 24 weeks ]
    The keloid or keloid scar will measured using the Silhouette Camera Imaging System

  2. Patient and Observer Scar Assessment Scale (Subject facing) [ Time Frame: 24 weeks ]
    Patient and Observer Scar Assessment to be completed by the subject with the physician.

  3. Patient and Observer Scar Assessment Scale (Non-Subject facing) [ Time Frame: 24 weeks ]
    Patient and Observer Scar Assessment to be completed by the physician only.

  4. Response Rate calculation [ Time Frame: 24 weeks ]
    Response Rate calculation = Complete Remission + Partial Response (RR= CR + PR)


Secondary Outcome Measures :
  1. Dermatology Quality of Life Index [ Time Frame: 24 Weeks ]
    Dermatology Quality of Life Index Questionaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03876548


Contacts
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Contact: Dianne Porral 855-564-2762 ext 1014 dporral@nextscience.com

Locations
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United States, Florida
Jacksonville Center for Clinical Research Recruiting
Jacksonville, Florida, United States, 32216
Contact: Amanda Pratt, RN    904-730-0101    apratt@encoredocs.com   
Contact: Gail Lowe, RN    904-730-0101    glowe@encoredocs.com   
Sponsors and Collaborators
Next Science TM
Jacksonville Center For Clinical Research
Investigators
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Principal Investigator: Michael Bernhardt, MD Jacksonville Center For Clinical Research

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Responsible Party: Next Science TM
ClinicalTrials.gov Identifier: NCT03876548     History of Changes
Other Study ID Numbers: CSP-008
First Posted: March 15, 2019    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Next Science TM:
keloid

Additional relevant MeSH terms:
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Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs