NCT06745999招募中4 期
A Single Center, Observational Study to Evaluate the Effectiveness and Safety of Cryotherapy in Combination with 10% ALA Gel Red Light PDT in the Treatment of Actinic Keratosis on the Full Face.
Psoriasis Treatment Center of Central New Jersey1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年5月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage change in total lesions at Week 24
研究概览
简要总结
40 patients randomized 1:1 to receive cryotherapy followed by 10% ALA gel Red light PDT vs. to 10% ALA gel Red Light PDT followed by cryotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult ≥ 18 years of age;
- •6-12 actinic keratosis grade I, II, and III on the full face.
- •Willing to avoid excessive sunlight or ultraviolet (UV) light exposure, including the use of tanning beds, to the face or scalp during study participation.
- •Females of childbearing potential (FCBP) must have a negative serum pregnancy test at Screening and negative urine pregnancy test at Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
- •Able and willing to give written informed consent prior to performance of any study-related procedures
排除标准
- •Presence of other skin conditions that may affect the study participant, investigator's ability to assess treatment, or intolerance to any ingredient in 10% ALA gel.
- •Treatment with 5-fluorouracil (5-FU), imiquimod, ingenol mebutate, diclofenac, photodynamic therapy, or other topicals and treatments for AK within the treatment area or within 2 cm of the treatment area, within 12 weeks of baseline.
- •Use of liquid nitrogen, excision, curettage, dermabrasion, chemical peel or laser resurfacing in the treatment area within 60 days.
- •Use of systemic retinoids (eg, isotretinoin, acitretin) within 6 months
- •Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating.
- •Use of any investigational drug within 4 weeks prior to enrollment or within 5 pharmacokinetic/pharmacodynamic half-lives, if known (whichever is longer).
- •Any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
研究组 & 干预措施
cryotherapy followed by 10% ALA gel Red light PDT
Experimental
干预措施: Red Light PDT (Device)
cryotherapy followed by 10% ALA gel Red light PDT
Experimental
干预措施: Cryotherapy (Procedure)
cryotherapy followed by 10% ALA gel Red light PDT
Experimental
干预措施: Ameluz 10% Topical Gel (Drug)
10% ALA gel Red Light PDT followed by cryotherapy
Experimental
干预措施: Ameluz 10% Topical Gel (Drug)
10% ALA gel Red Light PDT followed by cryotherapy
Experimental
干预措施: Red Light PDT (Device)
10% ALA gel Red Light PDT followed by cryotherapy
Experimental
干预措施: Cryotherapy (Procedure)
结局指标
主要结局
Percentage change in total lesions at Week 24
时间窗: 24 Weeks
Percentage change From Baseline in Total Lesion Complete Response at Week 24
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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