Initial Assessment of a Topical Cadexomer Iodine Gel Efficacy on Keloid Scar Revision: A Pilot Clinical Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Patient and Observer Scar Assessment Scale (Subject facing)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cadexomer Iodine Gel
Patients willy apply product to treatment site every other day for the next 28 days and cover with dressing or bandage.
干预措施: Cadexomer Iodine Gel (Device)
结局指标
主要结局
Patient and Observer Scar Assessment Scale (Subject facing)
时间窗: 24 weeks
Patient and Observer Scar Assessment to be completed by the subject with the physician.
Scar measurement with Silhouette Camera Imaging
时间窗: 24 weeks
The keloid or keloid scar will measured using the Silhouette Camera Imaging System
Patient and Observer Scar Assessment Scale (Non-Subject facing)
时间窗: 24 weeks
Patient and Observer Scar Assessment to be completed by the physician only.
Response Rate calculation
时间窗: 24 weeks
Response Rate calculation = Complete Remission + Partial Response (RR= CR + PR)
次要结局
- Dermatology Quality of Life Index(24 Weeks)