A Randomized, Double Blind Evaluation of the Effects of BOTOX® Cosmetic on Skin Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Skin quality assessment
研究概览
简要总结
This is a two cohort, randomized, double blind, single center study to evaluate the effects of Botox Cosmetic (BTX) on sebum protection. Thirty-four female subjects with moderate-to-high skin sebum concentration will be recruited and randomized in a 1:1 ratio to treatment groups.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age above 18 years.
- •Female sex.
- •A SebumeterTM score >66ug/cm2 at Baseline.
- •Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study.
- •Signed and dated informed consent to participate in the study and unrestricted use of facial images for marketing purpose.
- •If female of childbearing potential: a negative urine pregnancy test before all treatments is required.
- •Subject agrees to use the same topical cosmetic products (e.g., cleansers, moisturizers) throughout the duration of the trial, and at least for 30 days prior to enrolment.
- •Subject is on a stable diet and is not planning any major dietary changes throughout the duration of the trial.
- •Subject is not planning on undergoing any major hormonal changes throughout the duration of the study (e.g., menopause, change in medications).
排除标准
- •Current Pregnancy or lactation [sexually active women of childbearing age must agree to use medically acceptable methods of contraception for the duration of this study (e.g., oral contraceptives, condoms, intrauterine device, shot/injection, patch)];
- •Patients meeting any official BOTOX® Cosmetic contra-indications;
- •Inability to comply with follow-up and abstain from other treatments in the region of interest during the study period;
- •Heavy smokers, classified as smoking more than 12 cigarettes per day;
- •History of severe or multiple allergies manifested by anaphylaxis;
- •Previous tissue revitalization therapy in the treatment area within 6 months before treatment with laser or light, mesotherapy, radiofrequency, ultrasound, cryotherapy, chemical peeling, or dermabrasion;
- •Previous treatment with neurotoxins in the area under assessment, within 6 months prior to enrolment;
- •Previous treatment with soft tissue fillers in the area under assessment, within 6 months prior to enrolment;
- •Subjects presenting with known allergy to BOTOX® Cosmetic.
- •Subjects presenting with porphyria.
- •Subjects with active disease, such as inflammation, infection or tumors, in or near the intended treatment site.
- •History of bleeding disorders or treatment with thrombolytics, anticoagulants, or inhibitors of platelet aggregation (e.g. Aspirin or other non-steroid anti-inflammatory drugs [NSAIDs]), within 2 weeks before treatment.
- •Subjects using immunosuppressants.
- •Subjects prescribed systematic or topical (in the area under assessment) antibiotics within 1 month of enrolment.
- •Tattoos, piercings or visible markings that in the treating investigator's opinion, may interfere with results or assessments.
- •Cancer or precancer in the treatment area, e.g. actinic keratosis.
- •Patients with a tendency to form hypertrophic scars or any other healing disorders.
研究组 & 干预措施
Group 1
Subjects will receive BTX in the glabella and forehead regions, using a traditional injection technique commonly utilized in aesthetic medicine. The traditional injection technique will deposit the neurotoxin into the targeted muscles; with up to 24 units being injected into the forehead and 20 units in the glabella.
干预措施: Botox Cosmetic (Drug)
Group 2
Subjects will receive the traditional, deep injection technique, in addition to a superficial intradermal injection technique, which uses micro-aliquots of toxin. The superficial technique will deposit 0.1 units of toxin at 5mm intervals, at the level of the deep dermis.
干预措施: Botox Cosmetic (Drug)
结局指标
主要结局
Skin quality assessment
时间窗: Baseline versus Week 4
Reduction in sebum
次要结局
未报告次要终点
研究者
Andreas Nikolis
Medical Director
Erevna Innovations Inc.