An Evaluator-blind, Randomized, Vehicle-controlled Efficiency of Adjunctive Usage of a Moisturizer Containing Licochalcone A, L-carnitine and 1,2-decanediol With Adapalene Gel for Improvement of Local Tolerance in Thai Acne Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Skin Tolerability: Transepidermal Water Loss (TEWL)
研究概览
简要总结
Acne is an inflammation of sebaceous glands and follicles. Applying topical treatments such as adapalene gel may cause irritant adverse effects. Hence, using a moisturizer is another way to protect or relieve this undesirable event. Moisturizers that have anti-inflammatory property could reduce irritant effects, emergent from using topical treatment and also reduce severity of acne.
Research teams chose an adapalene gel to act as topical treatment for curing acne. It has anti-inflammatory and comedolytic effects and has fewer side effects than other groups of topical retinoic acids. However, peeling skin, redness skin, tingling sensation or itching sensation may occur if they are continually used for a long period. Thus, for the purpose of studying the efficacy of moisturizer containing licochalcone A, L-carnitine and 1,2-decanediol in reducing irritant effect of using adapalene gel (Licochalcone A has anti-inflammatory effect, L-carnitine decrease sebum production and 1,2-decanediol has anti-bacterial effect).
详细描述
The investigators team research with patients by separate patients into 3 groups and compare among each other. In the first group use only adapalene gel, the second group use adapalene gel with moisturizer containing three substances mentioned above, and the last group use adapalene gel with placebo moisturizer. To compare outcomes among 3 groups, the investigators will measure degree of redness, scale, oily face, moist, number of acne, quality of life, and satisfaction after using moisturizer.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years old or above
- •Participants have to control the birth for example, condom method, intrauterine device method before participate in the research at least 1 month until 6 months after research finish.
- •being diagnosed acne vulgaris by dermatologist in mild to moderate degree based on Investigators' Global Assessment scale of FDA
排除标准
- •Use oral or injected antibiotics or other oral medicine treating acne for example, isotretinoin, oral contraceptives, or spironolactone group during 4 weeks before participate this research
- •Have other active skin diseases at face during 2 weeks before participate the research
- •Allergic to adapalene gel and moisturizer
- •Have severe or uncontrolled underlying diseases
- •Getting pregnant or during breast feeding
- •Other types of acne(not acne vulgaris)
结局指标
主要结局
Skin Tolerability: Transepidermal Water Loss (TEWL)
时间窗: Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.
Skin tolerability was assessed by measuring TEWL with the Tewameter TM300
Skin Tolerability: Skin Sebum Content and Skin Hydration
时间窗: Skin tolerability was assessed at baseline and week 8. The changes of skin tolerability between baseline and 8th week of the 3 groups were compared.
Skin tolerability was assessed by measuring the skin surface sebum content, skin hydration with the Sebumeter SM815 and Corneometer CM825, respectively
Reduction of Undesirable Effects
时间窗: 2nd week, 4th week, and 8th week
* Undesirable effects were evaluated from skin's condition/signs(erythema, dryness and scaling) are evaluated by dermatologist. (none; mild; moderate; severe) and subject interview/symptoms(stinging/burning and pruritis) are evaluated by participants.(none; mild; moderate; severe). There were assessed at 2nd week, 4th week, and 8th week. * The worst score of each parameter which was defined as the worst local tolerance score is demonstrated and compared among 3 groups as shown.
次要结局
- Reduction of Severity of Acne(baseline, 2nd week, 4th week and 8th week)
- Reduction of Severity of Acne: Acne Severity Index (ASI)(baseline, 2nd week, 4th week and 8th week)