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临床试验/NCT04252352
NCT04252352Unknown不适用

Treatment of Acne Scars With Fractional CO2 Laser Versus Radio-frequency Microneedling: A Randomized Controlled Trial

Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2020年2月1日最近更新:
适应症

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

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

研究者

发起方
Aarhus University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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