Treatment of Acne Scars With Fractional CO2 Laser Versus Radio-frequency Microneedling: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Patient satisfaction
研究概览
简要总结
The study is a prospective, randomized, controlled, intra-person split-face trial with blinded evaluations. The objective is to compare efficacy and adverse effects of ablative fractional CO2 laser resurfacing versus radio-frequency microneedling for treatment of atrophic acne scars in the facial area. Two comparable areas with acne scars on each side of the face are treated. One area will be treated with fractional CO2 laser and the other area with radio-frequency microneedling.
Outcome measures will be assessed by blinded investigators and included subjects at baseline before treatment and at follow-up visits 2-4 days and 1 and 3 months post-treatment. On-site assessment and OCT will be performed at the time of the visits. OCT scans will be offered to the subjects and are optional. Clinical photos are used for documentation.
15 participants will be recruited. The participants will be recruited to enter the trial in the clinic by investigators at the Department of Dermatology, Bispebjerg Hospital, and must meet the inclusion criteria (at least 18 years of age, acne scars in the facial area, comparable atrophic acne scars on each side of the face, fitzpatrick skintype I-III) to be eligible to enter the study. No personal remuneration will be awarded the investigators. None of the collaborators have any personal economic interest in the study. Participants will not receive remuneration.
All treatments are performed at the Department of Bispebjerg Hospital and patients are covered by the Hospital's patient insurance.
The declaration of Helsinki will be respected as well as the standards of good clinical research. Respect for privacy as well as physically and mentally integrity of the participants will be maintained. The study will be performed in accordance with Danish Health care authorities.
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
- Single (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
- 是
入选标准
- •At least 18 years of age
- •Acne scars in the facial area (predominantly rolling scars)
- •Comparable atrophic acne scars on each side of the face
- •Fitzpatrick skintype I-III
排除标准
- •Pregnant or nursing women
- •Treatment with isotretinoin within the last 6 months
- •Current treatment with NSAID and prednisolone
- •Known tendencies to produce hypertrophic scars or keloids
- •Infection in the treatment area
- •Considered unable to follow the study protocol, e.g. alcohol dependence syndrome
结局指标
主要结局
Patient satisfaction
时间窗: 3 months
Adverse effects ( wounds, scars, pigmentation, erythema, edema)
时间窗: 3 months
Asymmetry (scar texture, erythema, pigmentation)
时间窗: 3 months
Optical coherence tomography
时间窗: 3 months
次要结局
未报告次要终点
