A Double Blind, Placebo Controlled, Randomised Dose Escalation Trial to Investigate the Safety and Efficacy of Topical Salbutamol in the Improvement of Scar Appearance When Applied to Approximated Wound Margins in Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Peak plasma concentration
研究概览
简要总结
This will be a single centre, double-blind, placebo (vehicle) controlled, randomised, dose escalation trial. Three concentrations of topical salbutamol gel will be compared, in a group-wise fashion, with a placebo administration at one incision site on each arm of the trial subjects. Each participant will be allocated to only one dosing group. The treatments will be paired anatomically so that for each pair of sites, one closed incision site will receive the active substance, while the other will receive placebo.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able, in the opinion of the investigator, and willing to give informed consent
- •Aged 18 - 50 inclusive, with both arms
- •Participants registered on The Over Volunteering Prevention System (TOPS) or equivalent in Leicester.
- •Body mass index within the range 15.0-35.0 kg/m
- •Inclusive (i.e. ≥ 15.0 and ≤ 35.0)
- •In the opinion of the investigator, clinically acceptable results for the laboratory tests specified in the trial protocol (see Protocol Section 11.2). All laboratory tests must be performed within 28 days of the subject's first trial dose administration.
- •Women of child bearing potential (WOCBP) must be using a highly effective means of contraception and agree to do so from at least the screening visit until trial end or completion of the trial.
排除标准
- •On direct questioning, have evidence of Left/Right Confusion.
- •On direct questioning and/or physical examination a history or evidence of keloid scarring.
- •On direct questioning have a family history of keloid scarring.
- •Tattoos or previous scars within 3cm of the area to be incised during the trial.
- •Surgery in the area to be incised and have surgical scars within 3cm of this area.
- •History of a bleeding disorder or who are receiving anti-coagulant or anti-platelet therapy.
- •On direct questioning and physical examination, have evidence of any past or present clinically significant disease that may affect the endpoints of the trial. For example: Coagulation disorders, diabetes, immuno-mediated conditions or allergies (including allergic contact dermatitis).
- •Subjects with a clinically significant skin disorder (dermatitis, eczema, psoriasis) that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
- •Any clinically significant medical condition or history that would impair wound healing including:
- •Rheumatoid arthritis.
- •Chronic renal impairment for their age.
- •Hepatic impairment (LFTs >3 times upper limit of normal).
- •Congestive heart failure.
- •Pre-existing ischemic heart disease
- •Pulmonary hypertension
- •Hypertrophic obstructive cardiomyopathy
- •Aortic stenosis
- •Current active malignancy or history of malignancy in the last 5 years.
- •Immunosuppression or chemotherapy within the last 12 months.
- •A history of radiotherapy at the areas to be studied.
- •Diabetes mellitus.
- •Subjects with proven diagnosis of thyroid disease
- •A history of hypersensitivity to any of the drugs or dressings used in this trial
- •Currently taking other prescribed treatments:
- •All corticosteroids, whether topically applied or systemic;
- •Any salbutamol containing preparations
- •Other beta-agonists, such as salmeterol
- •Any beta-blockers, such as propranolol
- •Other beta antagonists
- •Adrenaline
- •Undergoing investigations or changes in management for an existing medical condition.
- •History of drug abuse, including cocaine, amphetamines, methamphetamines, opiates or benzodiazepines.
- •In the opinion of the investigator, are unlikely to complete the trial for whatever reason.
- •Any clinically significant neurological impairment or disease, including body dysmorphia.
- •At entry into the trial, any active infection.
- •Pregnant or lactating or planning to become pregnant during the duration of the trial.
- •Not involved with any other clinical trial of medicinal product at the time of consent or 3 months prior.
研究组 & 干预措施
Placebo Gel
Each participant will be allocated to only one dosing group. The treatments will be paired anatomically so that for each pair of sites, one closed incision site will receive the active gel and the other placebo.
干预措施: Incision (Procedure)
Placebo Gel
Each participant will be allocated to only one dosing group. The treatments will be paired anatomically so that for each pair of sites, one closed incision site will receive the active gel and the other placebo.
干预措施: Placebo gel (Drug)
Active Gel
Each participant will be allocated to only one dosing group. The treatments will be paired anatomically so that for each pair of sites, one closed incision site will receive the active gel and the other placebo.
干预措施: Incision (Procedure)
Active Gel
Each participant will be allocated to only one dosing group. The treatments will be paired anatomically so that for each pair of sites, one closed incision site will receive the active gel and the other placebo.
干预措施: Active gel (Drug)
结局指标
主要结局
Peak plasma concentration
时间窗: 24 hours
The primary trial endpoint will be the peak plasma concentration of salbutamol at day 0.
次要结局
- Peak Plasma concentration 2(10 days)
- Efficacy of treatment using the Global Scar Comparison Scale(12 months)
- Efficacy of treatment using the Patient Observer Scar Assessment Scale(12 months)