A Randomized Phase II Double-Blinded Study of The Efficacy of Oleogel-S10 (AP101) Gel for the Treatment of Grade 2/3 Radiation Dermatitis in Breast Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Wound Surface Area Reduction of Radiation Dermatitis Grade 2-3 Wound Size From Baseline to Day 14 (+/- 3 Days)
研究概览
简要总结
The purpose of this study is find out whether Oleogel-S10 is an effective treatment for radiation dermatitis when it is used in combination with a standard wound treatment cream called triamcinolone. Oleogel-S10 has shortened the healing time for other types of skin wounds such as burns. Triamcinolone is a cream that is frequently used to treat moderate to severe skin conditions such as skin irritation caused by poison ivy, eczema, sunburn, and rashes.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients who are receiving PMRT to the chest wall or post-lumpectomy RT to the whole breast cancer of any stage
- •Age ≥ 18 years
- •Patients who develop ARD grade 2/3 after fraction day 20 (when receiving 25 total fractions) or after fraction day 25 when receiving (30 total fraction inclusive of a 5 fraction boost) of radiation therapy with all locations of desquamation
- •Able to self-administer topical interventions or provide for another person to apply the topical intervention
- •Patients may be started on any topicals prior to study enrollment. Once patient is enrolled on study (on or before Day 1), patient must be able to discontinue other topicals (including topical steroids, Silvadene, calcineurin inhibitors) to the treatment area
- •Patients have completed surgery or chemotherapy ≥ 4 weeks prior to start of radiation therapy. Patients may receive antibody-drug conjugates at any time before/during/after study
- •Women of childbearing potential (WCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline (Day 0) and documented monthly.
- •WCBP must agree to abstrain from sex or use a highly effective method of birth control* from the time of consent through visit
- •Adequate contraceptive methods include those with a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as abstinence from sexual intercourse, and some double barrier methods (condom with spermicide) in conjunction with use by the partner of an intrauterine device, diaphragm with spermicide, oral contraceptives, birth control patch or vaginal ring, or injectable or implanted contraceptives. Abstinence is acceptable only as true abstinence: when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- •A woman that is postmenopausal (≥2 years since last menstrual period) or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy) is not considered a WCBP.
排除标准
- •Patients who are receiving radiation therapy for inflammatory breast cancer or malignant fungating wound
- •Known history of allergy to any ingredient of the study medication
- •Patients with collagen-vascular disease/vasculitis
- •Patients receiving hypofractionated radiation therapy
- •Special populations:
- •patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent
研究组 & 干预措施
Triamcinolone + Oleogel-S10
25 participants will be randomized to triamcinolone 0.1% cream once every morning and topical Oleogel-S10 gel once prior to bedtime for a 3 week period.
干预措施: Triamcinolone Acetonide (Drug)
Triamcinolone + Oleogel-S10
25 participants will be randomized to triamcinolone 0.1% cream once every morning and topical Oleogel-S10 gel once prior to bedtime for a 3 week period.
干预措施: Oleogel-S10 (Drug)
Triamcinolone + Placebo
25 patients with breast cancer will be randomized to triamcinolone 0.1% cream once every morning (QAM) and vehicle gel once prior to bedtime for a 3 week period.
干预措施: Triamcinolone Acetonide (Drug)
结局指标
主要结局
Wound Surface Area Reduction of Radiation Dermatitis Grade 2-3 Wound Size From Baseline to Day 14 (+/- 3 Days)
时间窗: 14 days from baseline (+/- 3 days)
The primary outcome of this study is the efficacy of Oleogel-S10 in reducing radiation dermatitis grade 2-3 wound size in patient with breast cancer undergoing external beam radiation therapy. Clinical assessment at all study visits, including wound surface area and adverse events will be performed by a dermatologist. Wound size will be measured using a HIPAA compliant 3D clinical imaging system.
次要结局
未报告次要终点