NCT06475482已完成不适用
Development of a Novel Polyherbal Lip Hydrant for Improving Biophysical Barrier of the Lips
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Objective evaluation
研究概览
简要总结
- The goal of this clinical trial is to evaluate the efficacy of the novel polyherbal lip hydrant on dryness, fine lines and color of the lips in 66Thai people aged between 18-40 years old. The inclusion criteria will include subjects with subjective complaint of dry lips.The main question it aims to answer is Does the novel polyherbal lip hydrant improve biophysical barrier of the lips?
- Participant will be asked to apply the lip hydrant or the petroleum gel once a day before bedtime, and refrain from using other lip products throughout the clinical trial period (28 days).
- Researchers will compare control group (Petroleum gel) with lip hydrant group to see whether biophysical barrier (wrinkles, colors, fine lines, roughness) improve or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects with subjective complaint of dry lips;
- •agree to comply with the study protocol
- •agree not to apply any other products such as lipstick, lip gloss, lip conditioner to the lips other than the test product for the duration of the study
- •provide a written informed consent prior to study enrollment.
排除标准
- •Participants those having visible skin conditions which might interfere with the outcome assessment
- •having a history of sensitivities to cosmetics products, or moisturizers; - having a known or suspected intolerance or hypersensitivity to herbal products or any of its ingredient
- •taking medication or under the care of a doctor for one month prior to the commencement of the study, and throughout the entire test period
- •having other types of cheilitis except cheilitis simplex.
研究组 & 干预措施
Petroleum gel (Vaseline)
Placebo Comparator
control group
干预措施: Petroleum gel (Other)
Lip hydrant
Active Comparator
experimental group
干预措施: Lip hydrant (Other)
结局指标
主要结局
Objective evaluation
时间窗: 30 minutes per 1 participant
Objective evaluation; using * Fotofinder to take a photograph of the lips. * Modified visual assessment scale to assess lip roughness score divided to 4 levels (1=not dry 2= dry without desquamated 3 = dry with slightly desquamated 4 = dry with heavy desquamated) and lip wrinkle score divided into 3 levels (1 = Almost no vertical wrinkle 2 = No deep vertical wrinkle 3= Many deep vertical wrinkle) * Antera 3D. (Texture, wrinkle, melanin pigment and hemoglobin) the value from Antera appear as the number with no unit, * Digital camera to evaluate overall clinical improvement of the lips
次要结局
- Subjective evaluation(5 minutes per 1 participant)
研究者
研究点 (1)
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