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

Primary Purpose

Keloid Scar Following Surgery

Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cadexomer Iodine Gel
Sponsored by
Next Science TM
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jacksonville Center for Clinical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cadexomer Iodine Gel

Arm Description

Patients willy apply product to treatment site every other day for the next 28 days and cover with dressing or bandage.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Dermatology Quality of Life Index
Dermatology Quality of Life Index Questionaire

Full Information

First Posted
March 12, 2019
Last Updated
August 21, 2019
Sponsor
Next Science TM
Collaborators
Jacksonville Center For Clinical Research
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1. Study Identification

Unique Protocol Identification Number
NCT03876548
Brief Title
Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision
Official Title
Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision: A Pilot Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment Challenges
Study Start Date
February 7, 2019 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Next Science TM
Collaborators
Jacksonville Center For Clinical Research

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid Scar Following Surgery
Keywords
keloid

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Pilot study
Masking
None (Open Label)
Masking Description
Open label
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cadexomer Iodine Gel
Arm Type
Experimental
Arm Description
Patients willy apply product to treatment site every other day for the next 28 days and cover with dressing or bandage.
Intervention Type
Device
Intervention Name(s)
Cadexomer Iodine Gel
Intervention Description
Subjects will apply gel product to keloid scar site every other day for 28 days following keloid scar revision surgery.
Primary Outcome Measure Information:
Title
Scar measurement with Silhouette Camera Imaging
Description
The keloid or keloid scar will measured using the Silhouette Camera Imaging System
Time Frame
24 weeks
Title
Patient and Observer Scar Assessment Scale (Subject facing)
Description
Patient and Observer Scar Assessment to be completed by the subject with the physician.
Time Frame
24 weeks
Title
Patient and Observer Scar Assessment Scale (Non-Subject facing)
Description
Patient and Observer Scar Assessment to be completed by the physician only.
Time Frame
24 weeks
Title
Response Rate calculation
Description
Response Rate calculation = Complete Remission + Partial Response (RR= CR + PR)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Dermatology Quality of Life Index
Description
Dermatology Quality of Life Index Questionaire
Time Frame
24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bernhardt, MD
Organizational Affiliation
Jacksonville Center For Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States

12. IPD Sharing Statement

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

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