EUCTR2021-000934-32-DK进行中（未招募）1 期
A single-center, randomized double-blind, vehicle-controlled, dose-ranging decentralised clinical trial to evaluate the safety and efficacy of daily field-directed topical applications of AVX001 silicone-based gel in doses of 1% or 3% in adult subjects with multiple Actinic Keratosis lesions Olsen grade 1 or 2. - COAKs
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Participants must be= 18 years of age
- •2. Fluent in Danish
- •3. Actinic Keratosis (AK) diagnosed by Central assessors (based on uploaded photo)
- •4. Present an area of 25cm2 with 4 to 8 AK lesions located in face, neck or chest
- •5. AK lesions in target area severity grade 1 or 2 as defined by the Olsen clinical Criteria for AK
- •6. Able to and willing to follow trial procedures including application of AVX001 and using the Study App.
- •7. Have a suitable smartphone to complete the trial tasks (Android operating system: Android 8.0 or higher; iPhone with iOS 12.4 or higher
- •8. Female Subjects must either be of non-childbearing potential (either be surgically sterile (hysterectomy or tubal ligation) or post-menopausal) or must be using a highly effective method of contraception. Contraception must be maintained for the duration of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1. AK lesions classified as Olsen grade 3 in target area
- •2. Atypical AK lesions in the target area, including suspected SCC or BCC
- •3. Under suspicion of ,or current skin cancer diagnosis in the target area.
- •subjects who had BCC, SCC or melanoma and have completed curative therapy at least 12 months prior to screening and are in remission can be considered to participate in the trial by investigator’s discretion
- •4. Any dermatological condition in the target area that can be exacerbated by treatment or affect trial assessments, including but not limited to psoriasis vulgaris AD, rosacea, urticaria, scabies, and herpes simplex
- •5. Received immunosuppressive/immunomodulating drugs including but not limited to methotrexate, cyclosporine, azathioprine, oral retinoids, 6 months prior to baseline visit.
- •6. Received systemic corticosteroids including but not limited to betamethasone, prednisone, dexamethasone, metilprednisolone (except if via inhale or intranasal delivery) 6 months prior to baseline visit.
- •7. Received lesion or field directed therapy within 2 cm of the target area for trial treatment one month prior to baseline visit, including
- •topical drugs, including but not limited to topical fluorouracil, imiquimod, ingenol mebutate and diclofenac.
- •destructive therapies, including but not limited to surgery, cryotherapy, dermabrasion, and photodynamic therapy
- •field ablation treatments, including but not limited to chemical peels, laser resurfacing
- •8. Recipient of organ transplant including but not limited to bone marrow, kidney, liver, heart
- •9. Any unstable neurological or psychiatric disorder based on the investigator's opinion which has the potential to affect the safety of the subject, influence on trial objectives or impede the subject’s ability to complete the trial.
- •10. History of chronic alcohol or drug abuse within 12 months prior to screening or any condition associated with poor compliance at the investigator’s discretion
- •11. Received treatment with any non-approved drug substance within the last 4 weeks prior to baseline visit.
- •12. Known allergy or intolerance to fish, shellfish or fish oil
- •13. Concurrent participation in any other clinical trial or participation in any clinical trial treatments 4 weeks prior to enrollment.
- •14. Subject is pregnant or lactating
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