A Prospective, Randomized, Split-Face Pilot Study Comparing the Efficacy of the Institute of Dermatology's Antioxidant Moisturizing Serum in Mild to Moderate Seborrheic Dermatitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- SEDASI score
研究概览
简要总结
This is a 4-week comparison study between the intervention and control sides of the face. Purposive sampling to recruit 13 patients with seborrheic dermatitis will be conducted in this study. The study will start after researcher has been granted the Ethic Committee Approval. The process of subject recruitment and clinical data collection will take place at the Outpatient Department (OPD) while photograph taking and skin measurement will take place at Laser Center and Bioengineering Department, respectively. All bioengineering instruments will be operated under the climate controlled environment; i.e, at temperature 20+/-2 degree Celsius and 50+/-2 % of relative humidity. A subject must get acclimatized to the ambient atmosphere for at least 30 minutes. The clinical data, skin barrier function, the quality of life, subject's satisfaction scale will be collected at the first day (D0, as baseline) and 4th week after finishing the test product (Wk4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Gender: Male and Female
- •Patient who never uses or has stopped using topical corticosteroids/calcineurin inhibitor or other topical treatments exerting anti-inflammatory action (on the face) more than 2 weeks before entering this clinical trials.
- •Patient who does not use cosmetic containing any oxidants or others that exert anti-oxidant effect(s). If there is any, one must refrain from using them more than 2 weeks before entering this clinical trials.
排除标准
- •Patients with known cases of underlying HIV/AIDS, neurological condition e.g., Parkinson's disease.
- •Patient associated with any autoimmune diseases and other skin diseases
- •Patient takes any forms of oral immunotherapy more than 2 months up to the first day of clinical trials.
- •Patients continuously use of topical corticosteroids or other anti-inflammatory medicines on regular basis up to the first day of clinical trial.
- •Patient who refuses to stop using cosmetic(s) containing anti-oxidants or those exert anti-oxidant effect(s).
- •Patient who is allergic to the test product or one of its ingredients.
- •Pregnancy or nursing woman
研究组 & 干预措施
Intervention group
干预措施: Antioxidant moisturizing serum (Other)
结局指标
主要结局
SEDASI score
时间窗: 1 year
To compare clinical improvement as assessed by SEDASI score, between the intervention and control sides of the face in subjects with mild to moderate seborrheic dermatitis after 4 weeks of application of Institute of Dermatology's antioxidant moisturizing serum. This study uses split-face design. Due to the split-face study design and use of the SEDASI score, the same scoring scales were applied for extension (area, 0-6), presentation pattern (0-3), erythema (0-3), and scaling (0-3). The nasal area was excluded because split application to the nose is impractical. The original severity classification was therefore divided by two to obtain a hemiface-specific severity classification. Note: As the nasal area represents approximately 1% of the facial surface and the study compares the two sides of the face, this modification does not affect the primary study objective. The total score may range from 0 (no Seborrheic Dermatitis) to 30 (Seborrheic Dermatitis of the worst possible degree).
次要结局
- Skin Barrier function(4 weeks)