试验雷达 AI | ||
|---|---|---|
临床试验 NCT07401277 针对光化性角化病目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
一个试验符合筛选条件
卡片视图
返回搜索
西弗吉尼亚大学Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum I期 32
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT07401277旨在研究预防，主要针对光化性角化病。这是一项I期 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年3月1日开始，预计招募32名患者。该研究由西弗吉尼亚大学主导，计划于2027年8月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年2月10日。
简要概括
Actinic keratoses (AKs) are precancerous skin lesions most common among older white individuals and are prevalent throughout West Virginia. There is a risk of progression to cutaneous squamous cell carcinoma (SCC) when lesions are left untreated. Field-directed therapy with topical agents is used for patients with multiple lesions in a contiguous area. We propose that aluminum utilized for hemostasis is a contributin...显示更多
官方标题
Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum: an Exploratory Study
疾病
光化性角化病其他研究标识符
- 2501092203
主要目的
预防
分配方式
随机
干预模型
平行
盲法
双盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性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); ...显示更多 | 5% 5-fluorouracil (5-FU) powder Standard of care topical fluorouracil 5% cream, applied twice daily for seven consecutive days to designated side's AK lesions per protocol regimen. 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH) Investigational topical combination of fluorouracil 5% and acetyl cysteine 15%, applied twice daily for seven consecutive days to designated side's AK lesions per protocol regimen. |
实验性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...显示更多 | 5% 5-fluorouracil (5-FU) powder Standard of care topical fluorouracil 5% cream, applied twice daily for seven consecutive days to designated side's AK lesions per protocol regimen. 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH) Investigational topical combination of fluorouracil 5% and acetyl cysteine 15%, applied twice daily for seven consecutive days to designated side's AK lesions per protocol regimen. |
实验性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. | 5% 5-fluorouracil (5-FU) powder Standard of care topical fluorouracil 5% cream, applied twice daily for seven consecutive days to designated side's AK lesions per protocol regimen. 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH) Investigational topical combination of fluorouracil 5% and acetyl cysteine 15%, applied twice daily for seven consecutive days to designated side's AK lesions per protocol regimen. |
实验性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. | 5% 5-fluorouracil (5-FU) powder Standard of care topical fluorouracil 5% cream, applied twice daily for seven consecutive days to designated side's AK lesions per protocol regimen. 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH) Investigational topical combination of fluorouracil 5% and acetyl cysteine 15%, applied twice daily for seven consecutive days to designated side's AK lesions per protocol regimen. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Number of Actinic Keratoses; Baseline | Total numerical counts of actinic keratoses (AKs) assessed and documented. | Baseline |
Number of Actinic Keratoses; Day 8 | Total numerical counts of actinic keratoses (AKs) assessed and documented. | Day 8 |
Number of Actinic Keratoses; Day 56 | Total numerical counts of actinic keratoses (AKs) assessed and documented. | Day 56 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Skin redness at treatment site(s); Day 8 | Redness will be assessed using a scale of 0-4 as per the Clinical Erythema Assessment grading scale with: 0 = clear, 1 = almost clear, 2 = mild erythema, 3 = moderate erythema, and 4 = severe erythema with 0 being the best outcome. | Day 8 |
Skin redness at treatment site(s); Day 56 | Redness will be assessed using a scale of 0-4 as per the Clinical Erythema Assessment grading scale with: 0 = clear, 1 = almost clear, 2 = mild erythema, 3 = moderate erythema, and 4 = severe erythema with 0 being the best outcome. | Day 56 |
Skin itchiness at treatment site(s); Day 8 | Itchiness will be assessed using the Peak Pruritus Numeric Rating Scale (NRS) of 0-10 reported by the patient, with 0 being no itchiness and 10 being the worst itchiness ever experienced. | Day 8 |
Skin itchiness at treatment site(s); Day 56 | Itchiness will be assessed using the Peak Pruritus Numeric Rating Scale (NRS) of 0-10 reported by the patient, with 0 being no itchiness and 10 being the worst itchiness ever experienced. | Day 56 |
Pain at treatment site(s); Day 8 | Pain will be assessed using the Numeric Rating Scale (NRS) of 0-10 reported by the patient, with 0 being no pain and 10 being the worst pain ever experienced. | Day 8 |
Pain at treatment site(s); Day 56 | Pain will be assessed using the Numeric Rating Scale (NRS) of 0-10 reported by the patient, with 0 being no pain and 10 being the worst pain ever experienced. | Day 56 |
参与助手
资格标准
适龄参与研究
成人
最低年龄要求
18 Years
适龄性别
全部
- 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
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
西弗吉尼亚大学研究责任方
Joanna Kolodney, 主要研究者, Associate Professor, West Virginia University
研究中心联系人
联系人: Vlad Codrea, MD, PhD, 304-598-4548, [email protected]
1 位于 1 个国家/地区的研究中心
West Virginia
West Virginia University, Morgantown, West Virginia, 26505, United States
Vlad Codrea, MD, PhD, 联系人, 304-598-4548, [email protected]
Joanna Kolodney, MD, 主要研究者