Randomized, Multicenter, Double Blind Study to Compare the Efficacy and Tolerability of Oleogel-S-10 for 3 Month Versus Placebo Only in Patients With Mild to Moderate Actinic Keratoses Located at the Face and Head Oleogel-S-10 in Actinic Keratoses Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 4
- 主要终点
- Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.
研究概览
简要总结
In this study the impact of Oleogel-S-10 versus placebo on actinic keratoses over a treatment period of 3 months will be tested. Additionally, once and twice daily applications are tested.
详细描述
Oleogel-S-10 has shown efficacy and was well tolerated in two previous clinical trials. In the second open label phase II trial the efficacy of Oleogel-S-10 alone was similar compared to a more invasive treatment with cryotherapy. Response rates of 85% with a clear-ance of more than 75 % of the lesions of the patients treated with Oleogel-S-10 over three months were reported. These encouraging results led to the present randomized, multicenter, double blind phase II trial. The efficacy of the treatment shall be tested in a double blind placebo controlled (petroleum jelly) fashion in order to obtain more reliable results for the planning of a phase III study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •At least two mild to moderate actinic keratoses located at the facial skin or the head (except lips)
- •Actinic keratoses with a diameter of 0,5 - 2 cm,
- •that are definitely distinguished from other lesions and display a minimum distance of 0,5 cm to neighbored lesions
- •that are evaluated as histopathological grade 1 to 3
- •histologically proven AK within three months before study entry
- •prepared and able to give written informed consent
- •≥ 18 years of age
- •In case of females: postmenopause defined as
- •natural menopause with menses > 1 year ago
- •serum FSH (> 20 IU/l) and E2 levels in the postmenopausal range or
- •patients who had bilateral oophorectomy
- •prepared and comply with all study requirements, including the following:
- •application of Oleogel-S10 on the treatment area once or twice a day
- •4 clinic visits during the pre-study, treatment, post-treatment, and follow-up period
- •pre- and post-treatment biopsy for histological confirmation (of clearance) of AK-diagnosis
- •Representative histologic slide and tissue block were shipped
排除标准
- •Active immunosuppressive therapy
- •data of clinically significant, unstable, cardiovascular or hematologic, hepatic, neurologic, renal, endocrine, collagen-vascular, or gastrointestinal abnormalities or diseases Note: Patients with clinically stable medical conditions including, but not limited to, controlled hypertension, diabetes mellitus type II, hypercholesterolemia, or osteoarthritis will be allowed to enter the study
- •known allergies to any excipient in the study drug
- •any dermatological disease and/or condition in the treatment or surrounding area (3 cm distances from treatment area) that may be exacerbated by treatment with Oleogel-S-10 or cause difficulty with examination
- •active chemical dependency or alcoholism, as assessed by the investigator
- •pregnant and lactating women
- •currently participating in another clinical study or have completed another clinical study with an investigational drug within the past 30 days
- •received topical treatment at the treatment area with diclofenac gel, imiquimod or 5-FU within a time period of 1 month
- •Concomitant existence of non-treated (non-excised) basal cell carcinoma, squamous cell carcinoma or malignant melanoma
- •Invasive tumors within the treatment area, e.g.: merkel cell carcinoma, squamous cell carcinoma, basal cell carcinoma, the latter is accepted if completely surgically removed Note: A biopsy of any lesion within the treatment or surrounding area suggestive of malignancy should be performed at the pre-study screening visit. If invasive SCC or other malignant conditions are confirmed within the treatment area, the patient will not be included in the study.
研究组 & 干预措施
1
Oleogel-S10 100 mg/g ointment for three months once a day (54 patients)
干预措施: Oleogel-S10 100 mg/g (Drug)
2
Oleogel-S10 100 mg/g ointment for three months twice a day (54 patients)
干预措施: Oleogel-S10 100 mg/g (Drug)
3
Placebo (petroleum jelly) for three months once a day (27 patients)
干预措施: Placebo (petroleum jelly) (Drug)
4
Placebo (petroleum jelly) for three months twice a day (27 patients)
干预措施: Placebo (petroleum jelly) (Drug)
结局指标
主要结局
Objective Response of the Marker Actinic Keratosis, Defined as Histologically Complete or Partial Clearance.
时间窗: 18 weeks
Objective response of the marker actinic keratosis, defined as histologically complete or partial clearance (partial clearance = down-grading in Cockerell-classification). The marker actinic keratosis is defined as an initially selected lesion within the target area that will be used for final biopsy. The Cockerell classification refers to a single lesion, graded as the presence of atypical cells in the lower third of the epidermis (grade I), involvement of at least the lower two-thirds (grade II) or atypical keratinocytic proliferation in the entire epidermis (grade III). Thus a down-grading from a higher Cockerell grade (e.g., III) to a lower Cockerell grade (e.g., I) represents a positive outcome and treatment success.
次要结局
未报告次要终点