Multicentre, Double-Blind Trial to Evaluate the Efficacy and Safety of Lambdalina vs Placebo as an Anesthetic for Laser Hair Removal
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ISDIN
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Mean change in pain intensity (Pain Visual Analogue Scale) associated to laser hair removal from baseline to the end of laser hair removal session (primary endpoint)
研究概览
简要总结
Double-blind, randomized, placebo-controlled trial to assess the efficacy of Lambdalina (lidocaine cream) in reducing pain associated with laser hair removal in women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women ≥ 18 and ≤ 65 years old.
- •Laser hair removal treatment session in the legs in the area from the knee to the ankle (first or second application).
- •Able of accomplishing the study's requirements.
- •Negative result in the pregnancy test.
- •Sterile or surgically sterilized women (hysterectomy, tubal ligation) or using adequate contraceptive methods.
- •Written informed consent prior to inclusion in the trial.
排除标准
- •General exclusion criteria:
- •Pregnant or breastfeeding.
- •Current or previous medical conditions:
- •Skin type 5 or 6 or a history of photosensitivity.
- •Cardiovascular diseases such as unstable angina, or severe heart failure (New York Heart Association III or IV).
- •Neuropathy or paresthesia.
- •History of hepatic failure.
- •Autoimmune diseases.
- •Allergies to peanuts and/or soy and/or any components of the formulation.
- •Use or dependence on prohibited substances.
- •Other contraindications specified in the summary of product characteristics.
- •Current or previous concomitant medications:
- •Any anesthetic or analgesic treatment during 2 hours prior of study entry.
- •Concomitant treatment with antiarrhythmic drugs of class I (eg. tocainide, mexiletine) or class III (eg. amiodarone, sotalol), anticoagulants, anti-platelet aggregating and/or beta-blockers.
- •Active wounds or irritations in the area to be treated.
- •Topical treatment with corticosteroids or other topical agent in the area to be studied.
研究组 & 干预措施
Placebo and lambdalina
Eligible patients will receive placebo in Left Lower Extremity and lambdaline (lidocaine cream 40 mg/g) in Right Lower Extremity.
干预措施: Placebo (Drug)
Lambdalina and placebo
Eligible patients will receive lambdaline (lidocaine cream 40 mg/g) in Left Lower Extremity and placebo in Right Lower Extremity.
干预措施: Lambdalina® (Lidocaine 4% cream) (Drug)
Lambdalina and placebo
Eligible patients will receive lambdaline (lidocaine cream 40 mg/g) in Left Lower Extremity and placebo in Right Lower Extremity.
干预措施: Placebo (Drug)
Placebo and lambdalina
Eligible patients will receive placebo in Left Lower Extremity and lambdaline (lidocaine cream 40 mg/g) in Right Lower Extremity.
干预措施: Lambdalina® (Lidocaine 4% cream) (Drug)
结局指标
主要结局
Mean change in pain intensity (Pain Visual Analogue Scale) associated to laser hair removal from baseline to the end of laser hair removal session (primary endpoint)
时间窗: 30 minutes after treatment
次要结局
- Safety assessments including AEs and SAEs(48 hours after treatment)