NCT00748462已完成4 期
Clinical Quality Assurance Study: Fractional CO2 Treatment of Acne Scars in Asians
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- by the clinical investigator and graded into one of six categories: worse, no effect, slightly better, fair, good, and excellent. The results shall be reported.
研究概览
简要总结
The objective of this study is to investigate the efficacy and side effects of a fractional CO2 laser for treatment of acne scar in Asians.
详细描述
- The objective of this study is to investigate the efficacy and side effects of a fractional CO2 laser for treatment of acne scar in Asians.
- Study hypothesis
- Reduction in acne scars based on blinded evaluation of before photos and the one and three month follow-up photos after four full face Ellipse Juvia with low density treatments with a fluency of 90-105 mJ/MTZ is statistically significant (5%).
- The direct clinical blinded evaluated reduction in acne scars based on before photos and the patient in life, by the one and three month follow-up is statistically significant (5%)
- Reduction in fine lines based on blinded evaluation of before photos and the one and three month follow-up photos after four full face Ellipse Juvia with low density treatments with a fluency of 90-105 mJ/MTZ is statistically significant (5%).
- The direct clinical blinded evaluated reduction in fine lines based on before photos and the patient in life, by the one and three month follow-up is statistically significant (5%).
- Reduction in pigmented disorders based on blinded evaluation of before photos and the one and three month follow-up photos after four full face Ellipse Juvia with low density treatments with a fluency of 90-105 mJ/MTZ is statistically significant (5%).
- The direct clinical blinded evaluated reduction in pigmented disorders based on before photos and the patient in life, by the one and three month follow-up is statistically significant (5%).
- Improvements in skin texture and pore size based on blinded evaluation of before photos and the one and three month follow-up photos after four full face Ellipse Juvia with low density treatments with a fluency of 90-105 mJ/MTZ is statistically significant (5%).
- The direct clinical blinded evaluated reduction in skin texture and pore size based on before photos and the patient in life, by the one and three month follow-up is statistically significant (5%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Numbers of volunteers: 10 healthy men and women
- •Aged at least 30 year old
- •Skin type: 1 - 4
- •Degree of suntan: None - light
- •Skin condition: visible acne scars
排除标准
- •Fitzpatrick skin types 5-
- •Patients with lesions with any clinical suspicion of being pre-cancerous or skin malignancies of any kind.
- •Patients with skin diseases associated with Koebner phenomena.
- •Patients who have used Botox or filler injection to the periorbital or perioral regions 12 months prior or during the study.
- •Patients who have used topical retinoids, AHA under prescription or Vitamin C, 3 months prior to or during the study.
- •Patients who are pregnant or who wish to become pregnant and lactating women.
- •Patients who have been exposed to sun within 2 week from date of treatment.
- •Patients prone to hypertrophic scars or keloids
- •Patients who have previously undergone laser resurfacing may not be suitable for yet another procedure.
- •Patients undergoing oral retinoid therapy for acne in the past 6 months.
- •Patients who suffer from any serious medical condition, including diabetes, bleeding diathesis, delayed wound healing or prednisolone intake.
- •Patients with wound infections (herpes, other) on the day of treatment.
- •Patients with moderate and severe inflammatory acne, Immunosuppressed patients, History of vitiligo.
- •Patients with unrealistic concerns/expectations and inability to do the appropriate post-operative care.
结局指标
主要结局
by the clinical investigator and graded into one of six categories: worse, no effect, slightly better, fair, good, and excellent. The results shall be reported.
时间窗: Follow-up 1 and 3 months after the last treatment
次要结局
- The outcome and degree of satisfaction based on the before photo is evaluated by the patients themselves(Follow-up 1 and 3 months after the last treatment)
研究者
Woraphong Manuskiatti, M.D.
Professor
Mahidol University
研究点 (2)
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