Status:
WITHDRAWN
Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision
Lead Sponsor:
Next Science TM
Collaborating Sponsors:
Jacksonville Center For Clinical Research
Conditions:
Keloid Scar Following Surgery
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 unde...
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 under...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03876548
Start Date
February 7 2019
End Date
June 30 2019
Last Update
August 26 2019
Active Locations (1)
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1
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216