Single-Blinded Randomized Controlled Trial: Comparison of Quality of Life in Moderate Acne Vulgaris Patients Based on Acne-QoL-INA Using Standard Therapy With and Without Acne Lesions Extraction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Quality of Life Score
研究概览
简要总结
This study will compare the quality of life between 2 groups, which are group that receive standard moderate acne therapy in addition of lesion extractions, and the second group which only receive standard moderate acne therapy without lesion extractions.
详细描述
The group allocation will be randomized. Outcome of the study is the quality of life score based on Acne-QoL-INA questionnaire. The study duration is 8 weeks, consists of baseline visit and 2 follow ups at 4th and 8th weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinically diagnosed as moderate acne vulgaris
- •Able to read and speak in Indonesia
- •Indonesian Citizen
- •Sign the consent form
排除标准
- •Pregnant of breastfeeding women
- •Acne vulgaris lesion located only outside of face
- •Experiencing COVID-19 symptoms
- •Using retinoid acid containing cream or benzoil peroxide in the last 2 weeks
- •Consume any oral antibiotics in the last 1 month
- •Injected with intralesional steroid or having acne lesions extracted in the last 2 weeks
- •Having laser or chemical peeling in the last 1 month
研究组 & 干预措施
Intervention
Standard therapy and lesion extraction
干预措施: Lesion extraction (Procedure)
Control
Standard therapy without lesion extraction
干预措施: Tretinoin (Drug)
结局指标
主要结局
Quality of Life Score
时间窗: Every 4 weeks, measured until 8 weeks
Measured using Acne-QoL-INA questionnaire
次要结局
- Acne Grading(Every 4 weeks, measured until 8 weeks)
研究者
Christa Desire Gracia
Medical Doctor
Indonesia University