Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum: an Exploratory Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Actinic Keratoses; Baseline
研究概览
简要总结
This study is looking at a new way to treat actinic keratoses, which are rough, scaly spots on the skin caused by long-term sun exposure. These spots are common in older adults and, if not treated, can sometimes develop into a type of skin cancer.
Doctors often treat areas with many of these spots by using a prescription cream called 5-fluorouracil (5-FU), which helps remove damaged skin cells. This study is testing whether adding aluminum chloride hexahydrate, a medication commonly used to stop bleeding during skin procedures, can improve how well the cream works.
People who take part in this study will receive one of two treatments applied to their skin:
Standard treatment with 5% 5-fluorouracil cream, or A combination of 5% 5-fluorouracil cream plus 15% aluminum chloride hexahydrate cream
The treatment will be applied for one week. A dermatologist will examine the treated skin areas, count the number of actinic keratoses, and take photographs before treatment begins, shortly after treatment ends, and again about eight weeks later. These visits help researchers compare how well each treatment reduces the number of skin spots over time.
The goal of this study is to learn whether adding aluminum chloride hexahydrate to standard treatment helps reduce actinic keratoses more effectively than standard treatment alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Containers labeled A or B; identity of SOC 5% 5-FU vs investigational 5% 5-FU + 15% ACH concealed from participants and investigators.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than 50 years due to this being a pathology of adults that develops in chronically sun-damaged skin, individuals <50 years of age are excluded from this study.
- •Patients with 4-15 clinically diagnosed AKs on the scalp (16 patients) or on the forearms (16 patients) being followed at the Mohs Surgery clinic by WVU Medicine Dermatology
- •Performance status: ECOG Performance status less than or equal to 2
- •Patient must provide informed consent
排除标准
- •Presence of a suspected squamous cell carcinoma (SCC) or basal cell carcinoma (BCC) lesion or open wound on the treatment site (scalp or forearm)
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to 15% ACH or other agents used in this study
- •Use of one or more of the following products within the past month:
- •Tanning skin colorants
- •Prescription topical drugs
- •Immunomodulatory or immunosuppressive medicines
- •Chemotherapy or cytotoxic medications
- •Photodynamic therapy (PDT) or other treatments of pre-cancers on the skin
- •Vitamin A derivatives taken by mouth
- •Patients receiving any other investigational agents
- •Patients with immunosuppression or weakened immune systems who may be at a higher risk of infection, including patients who have had chronic lymphocytic leukemia (CLL), who have received transplants, or who are taking medications such as chronic steroids or rheumatoid arthritis (RA) drugs
研究组 & 干预措施
Split-Forearm: Left Investigational / Right SOC
Participants clinically diagnosed with AKs on the forearms will apply investigational cream (5% 5-FU + 15% ACH) to AK lesions on the left forearm and SOC cream (5% 5-FU) to AK lesions on the right forearm. Assignment is determined by sealed, randomized envelopes indicating "Container A to left" (with Container B to right); the identity of A vs B (SOC vs investigational) is blinded to participants and investigators.
干预措施: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH) (Drug)
Split-Forearm: Left SOC / Right Investigational
Participants clinically diagnosed with AKs on the forearms will apply SOC cream (5% 5-FU) to AK lesions on the left forearm and investigational cream (5% 5-FU + 15% ACH) to AK lesions on the right forearm. Assignment is determined by sealed, randomized envelopes indicating "Container A to right" (with Container B to left); the identity of A vs B (SOC vs investigational) is blinded to participants and investigators.
干预措施: 5% 5-fluorouracil (5-FU) powder (Drug)
Split-Scalp: Left Investigational / Right SOC
Participants clinically diagnosed with actinic keratoses (AKs) on the scalp will apply investigational cream (5% 5-fluorouracil [5-FU] + 15% acetyl cysteine [ACH]) to AK lesions on the left half of the scalp and standard of care (SOC) cream (5% 5-FU) to AK lesions on the right half of the scalp. Assignment is determined by sealed, randomized envelopes indicating "Container A to left" (with Container B to right); the identity of A vs B (SOC vs investigational) is blinded to participants and investigators.
干预措施: 5% 5-fluorouracil (5-FU) powder (Drug)
Split-Scalp: Left Investigational / Right SOC
Participants clinically diagnosed with actinic keratoses (AKs) on the scalp will apply investigational cream (5% 5-fluorouracil [5-FU] + 15% acetyl cysteine [ACH]) to AK lesions on the left half of the scalp and standard of care (SOC) cream (5% 5-FU) to AK lesions on the right half of the scalp. Assignment is determined by sealed, randomized envelopes indicating "Container A to left" (with Container B to right); the identity of A vs B (SOC vs investigational) is blinded to participants and investigators.
干预措施: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH) (Drug)
Split-Scalp: Left SOC / Right Investigational
Participants clinically diagnosed with AKs on the scalp will apply SOC cream (5% 5-FU) to AK lesions on the left half of the scalp and investigational cream (5% 5-FU + 15% ACH) to AK lesions on the right half of the scalp. Assignment is determined by sealed, randomized envelopes indicating "Container A to right" (with Container B to left); the identity of A vs B (SOC vs investigational) is blinded to participants and investigators.
干预措施: 5% 5-fluorouracil (5-FU) powder (Drug)
Split-Scalp: Left SOC / Right Investigational
Participants clinically diagnosed with AKs on the scalp will apply SOC cream (5% 5-FU) to AK lesions on the left half of the scalp and investigational cream (5% 5-FU + 15% ACH) to AK lesions on the right half of the scalp. Assignment is determined by sealed, randomized envelopes indicating "Container A to right" (with Container B to left); the identity of A vs B (SOC vs investigational) is blinded to participants and investigators.
干预措施: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH) (Drug)
Split-Forearm: Left Investigational / Right SOC
Participants clinically diagnosed with AKs on the forearms will apply investigational cream (5% 5-FU + 15% ACH) to AK lesions on the left forearm and SOC cream (5% 5-FU) to AK lesions on the right forearm. Assignment is determined by sealed, randomized envelopes indicating "Container A to left" (with Container B to right); the identity of A vs B (SOC vs investigational) is blinded to participants and investigators.
干预措施: 5% 5-fluorouracil (5-FU) powder (Drug)
Split-Forearm: Left SOC / Right Investigational
Participants clinically diagnosed with AKs on the forearms will apply SOC cream (5% 5-FU) to AK lesions on the left forearm and investigational cream (5% 5-FU + 15% ACH) to AK lesions on the right forearm. Assignment is determined by sealed, randomized envelopes indicating "Container A to right" (with Container B to left); the identity of A vs B (SOC vs investigational) is blinded to participants and investigators.
干预措施: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH) (Drug)
结局指标
主要结局
Number of Actinic Keratoses; Baseline
时间窗: Baseline
Total numerical counts of actinic keratoses (AKs) assessed and documented.
Number of Actinic Keratoses; Day 8
时间窗: Day 8
Total numerical counts of actinic keratoses (AKs) assessed and documented.
Number of Actinic Keratoses; Day 56
时间窗: Day 56
Total numerical counts of actinic keratoses (AKs) assessed and documented.
次要结局
- Skin redness at treatment site(s); Day 8(Day 8)
- Skin redness at treatment site(s); Day 56(Day 56)
- Skin itchiness at treatment site(s); Day 8(Day 8)
- Skin itchiness at treatment site(s); Day 56(Day 56)
- Pain at treatment site(s); Day 8(Day 8)
- Pain at treatment site(s); Day 56(Day 56)
研究者
Joanna Kolodney
Associate Professor
West Virginia University