Prospective, Randomized Control Trial to Evaluate the Dermatological Reaction of Healthy Volunteers to Gellan Sheet and Fluid Gel Dressings (Gellan Contact Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Skin reaction
研究概览
简要总结
The primary objective of this study will be to establish the safety of the two different Gellan formulations (sheet and fluid gel) following its application to the epidermis of healthy volunteers. This will be compared to a control dressing-- Mepitel One (Polyurethane net with soft Silicone).
详细描述
This contact study is part of the Wellcome trust Anti-scarring Dressing project to develop a carrier dressing that will be used to deliver therapeutic agents to the skin. A polysaccharide, Gellan, has been chosen as the main component of this dressing (the biomembrane)and it can be produced in either a sheet or fluid gel forms. Gellan is a widely used material in both the food and medical industry e.g. as a lubricant in eye-drops (e.g. Timoptol XE, Merck Sharp & Dohme, USA).
As part of the development of the dressing, the epidermal (skin) response to Gellan needs to be evaluated to check its safety.
The main objective of this study is to establish the safety of the two different Gellan formulations (2% Gellan sheet and 2% Gellan fluid gel) following application to the epidermis (skin).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Two assessors will be evaluating the skin for erythema, dryness and oedema. They will be blinded to which arm has received the treatment and control.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects aged ≥ 18 years old
- •Subjects who can provide informed consent
排除标准
- •Subject with existing skin conditions/diseases which may interfere with the aim(s) of the study. Examples include pathological fibrosis e.g. scleroderma; pathological thinning e.g. epidermolysis bullosa and collagen disorders e.g. Marfan's syndrome
- •Chronic steroid use, history of skin malignancy or chronic papulo-squamous disease (e.g. eczema, pemphigus) and history of Steven Johnson or TENS disease
- •Blemishes, marks (e.g. tattoos, scars or burns,) on the test site(s) which may interfere with assessment on the test site
- •Use of medication which may affect may affect skin response
- •Known allergy to the materials used in the study
- •Known allergy to adhesive plasters or tapes
- •Fitzpatrick skin type VI (due to the difficulty of identifying erythema)
- •Irritated skin on the test site
- •Known pregnancy (confirmed by urine pregnancy test) or lactating
- •Inability to commit to attending all sessions.
- •Participation in another study which may affect the results of this contact study.
- •Any other reason that clinician considers will interfere with the objectives of the study
研究组 & 干预措施
Arm C
Left arm: Gellan fluid gel; Right arm: Mepitel One.
干预措施: Mepitel One (Device)
Arm D
Left arm: Mepitel One; Right arm: Gellan fluid gel.
干预措施: Gellan fluid gel (Device)
Arm D
Left arm: Mepitel One; Right arm: Gellan fluid gel.
干预措施: Mepitel One (Device)
Arm A
Left arm: Gellan sheet; Right arm: Mepitel One.
干预措施: Gellan sheet (Device)
Arm A
Left arm: Gellan sheet; Right arm: Mepitel One.
干预措施: Mepitel One (Device)
Arm B
Left arm: Mepitel One; Right arm: Gellan sheet.
干预措施: Gellan sheet (Device)
Arm B
Left arm: Mepitel One; Right arm: Gellan sheet.
干预措施: Mepitel One (Device)
Arm C
Left arm: Gellan fluid gel; Right arm: Mepitel One.
干预措施: Gellan fluid gel (Device)
结局指标
主要结局
Skin reaction
时间窗: 3 days (72 hours+/-3 hours)
Skin will be evaluated for erythema, dryness and oedema by two observers using a visually based scale (Visual skin assessment scale; this is a novel scale devised by the research team). The scale is as follows: 1. Erythema: 0-4 (Higher values are worse) 2. Dryness: 0-3 (Higher values are worse) 3. Oedema: 0-1 (Higher values are worse) Each subscale is evaluated individually and not combined.
次要结局
- Participant satisfaction with dressing(At end of study (after 3 days))
- Clinician satisfaction with dressing(At end of study (after 3 days))