A Randomized Right/Left Clinical Trial to Evaluate the Use of Biafine Cream Versus Standard Care in Subjects With Actinic Keratosis Post Cryotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean Severity Score
研究概览
简要总结
The purpose of this research study is to evaluate the use of Biafine Cream on wounds created by removal of actinic keratosis using cryotherapy in a clinical setting.
详细描述
Subjects were randomized to apply Biafine® to wounds on one forearm and polysporin (standard of care) to wounds on the other. Medications were applied three times a day for 4 weeks to the areas that have been treated with cryotherapy at the baseline visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must give written consent.
- •Subjects must be >50 years of age, male or female.
- •Subjects must have had cryotherapy treatment of at least one AK's on each forearm in the Dermatology Clinic.
排除标准
- •Subjects age <50 years of age.
- •Subjects with known allergy or sensitivity to topical Biafine or polysporin ointment.
- •Inability to complete all study-related visits.
- •Introduction of any other prescription medication, topical or systemic, for AK while participating in the study.
- •Subjects using other topical agent's glycolic acid products, alpha-hydroxy acid products, retinoids and chemical peel agents in the treatment areas while on study.
研究组 & 干预措施
Biafin on left arm
Subjects were randomized to apply Biafine® to wounds on the left forearm and polysporin (standard of care) to wounds on the right forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.
干预措施: Biafine (Drug)
Biafin on left arm
Subjects were randomized to apply Biafine® to wounds on the left forearm and polysporin (standard of care) to wounds on the right forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.
干预措施: Polysporin (Drug)
Biafin on right arm
Subjects were randomized to apply Biafine to wounds on the right forearm and Polysporin to wounds on the left forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.
干预措施: Biafine (Drug)
Biafin on right arm
Subjects were randomized to apply Biafine to wounds on the right forearm and Polysporin to wounds on the left forearm. Medications were applied three times a day for 4 weeks to the areas that have been treated with liquid nitrogen at the baseline visit.
干预措施: Polysporin (Drug)
结局指标
主要结局
Mean Severity Score
时间窗: 4 weeks
The change in the Mean Severity Score from Baseline to Week 4 (or end of treatment) as measured by the Mean Combined Severity Scores for Erythema, Scab, and Thickness on a scale of 0-4 with 0=None 1=slight 2=mild 3= moderate 4= severe
次要结局
未报告次要终点