Effectiveness of Comedone Extraction and Oral Doxycycline In The First Line Treatment of Moderate Acne Vulgaris: Study on HIF-1 Alpha Expression
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- Change from Baseline Non-Inflammatory Lesions at 6 weeks
研究概览
简要总结
The objective of the study was to evaluate the effectiveness of comedone extraction compared to oral antibiotics as the main therapy of moderate acne vulgaris (MAV); and to determine the expression of HIF-1 alpha by examining the immunohistochemistry and ELISA as a sign of hypoxia/anoxia in MAV lesion. This was a randomized, placebo-controlled clinical trial that was performed in 2015 at three different dermatology clinics in Indonesia, Cipto Mangunkusumo Hospital Jakarta, Gatot Soebroto Army Hospital Jakarta, and PT. Mattel Indonesia, Cikarang. One hundred and twenty eight subjects with moderate acne vulgaris were recruited and randomized to receive either oral doxycycline or comedone extraction for six weeks. Subjects who had acne lesion and the back area were offered skin lesion biopsy to evaluate immunohistochemistry and ELISA before administration of medication. The main outcome was total reduction of inflammatory and non inflammatory lesions, evaluated every two weeks.
详细描述
Acne vulgaris (AV) is a polymorphic disease, characterized by inflammatory and noninflammatory lesions. Systemic antibiotics play a role as the first line therapy of moderate acne vulgaris treatment. Since bacterial resistance tends to increase, alternative therapy for moderate acne vulgaris is needed.
This study aims to evaluate the effectiveness of comedone extraction compared to oral antibiotics as the main therapy of moderate acne vulgaris; and to etermine the expression of HIF-1 alpha by examining the immunohistochemistry and ELISA as a sign of hypoxia/anoxia in MAV lesion.
This was a randomized, placebo-controlled clinical trial that was performed in 2015 at three different dermatology clinics in Indonesia, Cipto Mangunkusumo Hospital Jakarta, Gatot Soebroto Army Hospital Jakarta, and PT. Mattel Indonesia, Cikarang.
One hundred and twenty eight subjects, aged between 15 and 50 years, with moderate acne vulgaris were recruited and randomized to receive either oral doxycycline (100 mg) or comedone extraction for six weeks. Subjects who had acne lesion and the back area were offered skin lesion biopsy to evaluate immunohistochemistry and ELISA before administration of medication.
At each follow-up visit, subjects were asked to grade the overall response and questioned regarding adverse events. The objective or main outcome was total reduction of inflammatory and noninflammatory lesions.
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
- None
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with moderate acne vulgaris based on clinical manifestation of face (20-100 comedones, 15-50 inflammatory lesions, and/or 30-125 total lesions)
- •Age range of 15 to 50 years old
排除标准
- •History of oral antibiotics consumption within 2 weeks preceding this study
- •Usage of topical retinoid in less than previous 2 weeks
- •History of systemic retinoid consumption within 3 months preceding this study
- •Pregnant of breastfeeding women
- •Consuming oral contraception during examination
- •Drug allergy or skin manifestation due to side effect of moderate acne vulgaris first line therapy
研究组 & 干预措施
Doxycycline Group
Subjects were randomized to receive Doxycycline capsules. The capsules were taken once daily for 6 weeks and evaluated every 2 weeks.
干预措施: Doxycycline Capsule (Drug)
Comedone Extraction Group
Subjects were randomized to receive comedone extraction. Comedone extraction were done three times, and evaluated every 2 weeks.
干预措施: Comedone extraction (Procedure)
结局指标
主要结局
Change from Baseline Non-Inflammatory Lesions at 6 weeks
时间窗: 6 weeks
Numeric data of total reduction (improvement) of non-inflammatory lesions (Baseline non-inflammatory lesion count) - (Week 6 non-inflammatory lesion count) __________________________________________________________ x 100% Baseline non-inflammatory lesion count
Change from Baseline Non-Inflammatory Lesions at 4 weeks
时间窗: 4 weeks
Numeric data of total reduction (improvement) of non-inflammatory lesions (Baseline non-inflammatory lesion count) - (Week 4 non-inflammatory lesion count) __________________________________________________________ x 100% Baseline non-inflammatory lesion count
Change from Baseline Inflammatory Lesions at 4 weeks
时间窗: 4 weeks
Numeric data of total reduction (improvement) of inflammatory lesions (Baseline inflammatory lesion count) - (Week 4 inflammatory lesion count) __________________________________________________________ x 100% Baseline inflammatory lesion count
Change from Baseline Inflammatory Lesions at 2 weeks
时间窗: 2 weeks
Numeric data of total reduction (improvement) of inflammatory lesions (Baseline inflammatory lesion count) - (Week 2 inflammatory lesion count) __________________________________________________________ x 100% Baseline inflammatory lesion count
Change from Baseline Inflammatory Lesions at 6 weeks
时间窗: 6 weeks
Numeric data of total reduction (improvement) of inflammatory lesions (Baseline inflammatory lesion count) - (Week 6 inflammatory lesion count) __________________________________________________________ x 100% Baseline inflammatory lesion count
Change from Baseline Non-Inflammatory Lesions at 2 weeks
时间窗: 2 weeks
Numeric data of total reduction (improvement) of non-inflammatory lesions (Baseline non-inflammatory lesion count) - (Week 2 non-inflammatory lesion count) __________________________________________________________ x 100% Baseline non-inflammatory lesion count
次要结局
- Number of Participants with Side Effects at 6 weeks(6 weeks)
- Subjective Improvement at 2 weeks(2 weeks)
- Subjective Improvement at 4 weeks(4 weeks)
- Number of Participants with Side Effects at 4 weeks(4 weeks)
- Subjective Improvement at 6 weeks(6 weeks)
- Number of Participants with Side Effects at 2 weeks(2 weeks)
研究者
Dr.dr.Irma Bernadette, SpKK (K)
Irma Bernadette S. Sitohang, MD, PhD - Head of Division of Cosmetic Dermatology, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia, dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia
Indonesia University